Quick Access to Global Markets

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Quick Access to Global Markets Overview of Compliance Requirements for Electrical and Electronic Goods in Leading Regions and Countries TÜV SÜD Quick Access to Global Markets 1 Global Market Access 3 2 International Compliance Management5 3 Application of the E-Guidebook to Global Market Access Where to Obtain More Information 4 Medical Device 32 Environmental33 Country Regulations United States of America (USA)34 Electrical Safety 34 Telecoms35 8 Wireless35 9 EMC36 Medical Device 37 Environmental38 11 European Union (EU) 11 Russia14 Electrical Safety 14 Telecoms & Wireless 15 Medical Device 16 Environmental17 Australia39 Electrical Safety 39 Telecoms40 Wireless & EMC 41 Medical Device 42 Environmental43 Argentina18 Electrical Safety 18 Telecoms & Wireless 19 Medical Device 20 Environmental21 New Zealand 44 Electrical Safety 44 Telecoms45 Wireless & EMC 46 Medical Device 47 Environmental48 Brazil22 Electrical Safety 22 Telecoms & Wireless 23 Medical Device 24 Environmental25 Brunei Darussalam 49 Electrical Safety 49 Telecoms & Wireless 50 Medical Device 51 Environmental52 Canada26 Electrical Safety 26 Telecoms & Wireless 27 EMC27 Medical Device 28 Environmental29 Cambodia53 Electrical Safety 53 Telecoms & Wireless 54 Medical Device 55 Environmental56 Mexico30 Electrical Safety 30 Telecoms & Wireless 31 China57 Electrical Safety 57 Telecoms59 Wireless60 Medical Device 61 Environmental62 Hong Kong 64 Electrical Safety 64 EMC64 Telecoms & Wireless 66 Medical Device 67 Environmental68 India69 Electrical Safety 69 Telecoms71 Wireless71 Medical Device 72 Environmental73 Indonesia74 Electrical Safety 74 Telecoms & Wireless 75 Medical Device 76 Environmental77 Japan78 Electrical Safety 78 Telecoms & Wireless 79 EMC79 Medical Device 80 Environmental81 Korea (South) 83 Electrical Safety 83 Telecoms & Wireless 85 Medical Device 86 Environmental87 Malaysia88 Electrical Safety 88 Telecoms & Wireless 89 Medical Device 91 Environmental92 Philippines93 Electrical Safety 93 Telecoms & Wireless 94 Medical Device 95 Environmental96 Singapore97 Electrical Safety 97 Telecoms & Wireless 98 Medical Device 100 Environmental101 Taiwan102 Electrical Safety 102 Telecoms & Wireless 104 EMC104 Medical Device 105 Environmental106 Thailand107 Electrical Safety 107 Telecoms & Wireless 108 Medical Device 110 Environmental111 5 Telecoms & Wireless 122 Medical Device 123 Environmental124 Saudi Arabia 125 Electrical Safety 125 EMC125 Telecoms & Wireless 126 Medical Device 127 Environmental128 United Arab Emirate (UAE)129 Electrical Safety 129 Telecoms & Wireless 130 Medical Device 131 Environmental132 South Africa 133 Electrical Safety 133 Telecoms & Wireless 134 EMC134 Medical Device 135 Environmental136 TÜV SÜD Group 137 Vietnam112 6 Quick reference guide 139 Electrical Safety 112 Index143 Telecoms & Wireless 113 Medical Device 115 Environmental116 Israel117 Electrical Safety 117 Telecoms118 Wireless118 Medical Device 119 Environmental120 Kuwait121 Electrical Safety 121 2 Quick Access to Global Markets 01 01 Global Market Access Global Market Access 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA Global Opportunities Global Challenges The liberalization of markets and greater effort in international trade cooperation has resulted in an almost borderless world. Goods, services, people, capital and ideas are being exchanged at a faster rate than ever before. Although there are lesser trade barriers today, businesses face challenges in the form of “technical trade barriers”. Those who embrace the opportunities abroad stand to benefit from the access to markets once thought impossible. The result: increased global presence, market share and ultimately higher profit. “Technical trade barriers” are restrictions that governments place in the form of product testing and certification requirements. Manufacturers have to overcome these barriers in order to access new countries and their markets. 05 TÜV SÜD Group 06 Quick Reference Overview The regulatory framework is becoming increasingly complex in view of countries drafting and enforcing more regulations, as well as constantly 3 Quick Access to Global Markets 01 01 Global Market Access updating these regulations to include a greater scope of areas such as social compliance, business conformity, and environment in addition to product safety and Electromagnetic Compliance (EMC). Addressing the Challenges Creating a product that meets the requirements of all the leading markets of the world is a rewarding and sustainable approach for manufacturers. A world of opportunity opens up when a product meets all the compliance requirements of target markets. However, the process of obtaining separate approvals for each market can be complicated, time-consuming and costly. If it is not handled competently, the process can add substantial cost and delay the time to market, causing a company to lose its competitive edge despite having a superior product. The involvement of an experienced compliance expert, such as TÜV SÜD, enables manufacturers to meet the product safety, EMC and other requirements of target countries in an efficient and cost-effective way. Product certifications by TÜV SÜD can also minimize product liability risks and act as a strong marketing advantage against competition. Global Market Access Here are 3 tips for quick market access: • Be aware of the regulations and product testing and certification requirements of target countries and regions. • Attend seminars by organizations with expertise in the field of International Compliance Management (ICM). • Seek advice from ICM specialists like TÜV SÜD even before designing products. An early understanding of electrical safety, EMC, telecoms and wireless conformity requirements of different countries can avoid noncompliances and save costly redesign efforts. 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 4 Quick Access to Global Markets 01 02 International Compliance Management Global Market Access 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA International Compliance Management (ICM) is a systematic process of managing compliance with regulations for manufacturers to gain access to global markets. ICM enables manufacturers to comply with the regulations and standards of target countries and regions, and obtain necessary approvals. Benefits of ICM With ICM, manufacturers can significantly reduce cost and the time to market its products. For example: • Having a single interface dealing with regulators of target markets will allow logistic issues for each country of destination to be resolved smoothly. • Single test for one product or a family of models, accounting for national differences, will reduce time-to-market and cost of multiple tests. • Regular and timely updates of changes in the global regulatory landscape by an ICM partner will allow manufacturers to be better prepared on issues affecting their operations. 05 TÜV SÜD Group 06 Quick Reference Overview 5 Quick Access to Global Markets 01 02 International Compliance Management ICM Avenues Manufacturers require a unique ICM solution, depending on the product category and target market. The ICM solution revolves around five main avenues: 1. Governmental MRAs (Mutual Recognition Agreements) An efficient ICM solution, this involves making use of inter-governmental recognition of each other’s Certification Bodies (CB) and approvals. MRAs promote cross border stakeholder confidence and the acceptance of accredited conformity assessment bodies (CAB). This negates the need for duplicative testing, inspection or calibration of goods upon entry to importing countries. TÜV SÜD is a designated CAB for numerous products in countries across the globe. 2. Third-party Accredited Bodies Local regulators define the requirements for CBs to be accredited for the provision of third-party certification services. Engaging a third-party accredited body like TÜV SÜD provides businesses and their stakeholders with the assurance that a formalized and structured approach to attaining the certification is applied and without bias. The TÜV SÜD Group holds many accreditations granted by numerous regulatory bodies across the globe. Manufacturers can benefit from the global, third-party recognition that certification provides and even use their certification as a stepping stone to a more expedient ISO certification. Global Market Access 3. Bilateral Agreements This avenue involves bilateral agreements, or Memorandums of Understanding (MOU), between target countries’ CBs. This allows one CB to obtain approvals or certifications for products from another, where is it required or requested. TÜV SÜD has bilateral agreements with a number of certification agencies, such as: • Korea Testing Laboratory (KTL) • Japanese Quality Assurance Organization • Saudi Arabian Standards Organization (SASO) 4. Multilateral Agreements These agreements are based on mutual recognition of multiple national CBs. For example, as a member of the CB Scheme – also known as the Scheme of the International Electrotechnical Commission System for Conformity Testing and Certification of Electrical Equipment (IECEE) – TÜV SÜD offers manufacturers and exporters an opportunity to increase global marketability. The scheme facilitates the international exchange and acceptance of product-safety test results among participating CBs for national approval or certification in one or more countries, normally without the need for additional testing. It covers 50 participating countries, 65 National CBs and 259 testing laboratories. 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 6 Quick Access to Global Markets 01 02 International Compliance Management 5. Interface with Regulators In some cases, it is required that certification is issued by the target country’s regulatory agency. Dealing directly with a target country’s regulatory agency can be a frustrating and expensive process. On behalf of its customers, TÜV SÜD can obtain the necessary approvals and certification from the target country’s agency in an effort to expedite and ease the process. TÜV SÜD ICM Services To market and sell products in today’s global economy, staying abreast of rapidly changing regulations for each individual country can be an exhausting task. To meet this challenging demand, TÜV SÜD offers a host of ICM services to assist organizations in gaining country specific product certifications and quality registrations. Any enterprise that desires to introduce its products into the global market requires a competent partner by its side. Through its experience and capabilities, TÜV SÜD will provide experts that understand each manufacturer’s unique approval requirements, saving precious time and resources in bringing products to the global market. With a global network of offices, TÜV SÜD has created a unique level of competence in individual country requirements – a network that leverages manufacturers’ particular needs while breaking down cultural barriers through communication. Global Market Access Manufacturers can benefit from TÜV SÜD’s comprehensive services: • Advice on respective countries’ compliance requirements and approval strategy • Product testing and certification • Review of test data to ensure compliance for design changes, where necessary • Prepare and complete application package and interfacing with regulatory officials • Post-submission follow up with authorities 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 7 Quick Access to Global Markets 03 Application of the E-Guidebook to Global Market Access Scope of the E-Guidebook • Electrical Safety • Electromagnetic Capability (EMC) • Telecoms • Wireless • Medical Device • Environmental* This E-Guidebook presents key market-entry conformity requirements for quick access to global markets. It demonstrates the importance of accounting for these requisites early in the product design phase to shorten product launch cycles and maximize profitability. Australasia Australia New Zealand Application of the Guidebook 04 Asia Brunei Darussalam Cambodia China Hong Kong India Indonesia Japan Korea (South) Malaysia Philippines Singapore Taiwan Thailand Vietnam Middle East Africa South Africa Israel Kuwait Saudi Arabia United Arab Emirates Glossary of Commonly Used Abbreviations CAB CB CoC DoC MOU Conformity Assessment Body Certification Body Certificate of Conformity Declaration of Conformity Memorandum of Understanding 02 03 Country List The Americas Argentina Brazil Canada Mexico United States of America Global Market Access International Compliance Management Readers will acquire valuable information on regulatory agencies, conformity requirements, application guidelines, product categories for more than 25 countries across the globe. It’s a guide on all you need to know about regulatory requirements in key markets, packed with tips from the experts and how TÜV SÜD can help. Europe European Union Russia 01 MRA RAB RCAB RCB SDoC Mutual Recognition Agreement Registered Assessment Body Registered Conformity Assessment Body Registered Certification Body Supplier’s Declaration of Conformity Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview * Environmental requirements may cover energy efficiency, restriction of the use of certain hazardous substances (RoHS), and Waste Electrical and Electronic Equipment (WEEE) requirements. 8 Quick Access to Global Markets 01 03 Application of the E-Guidebook to Global Market Access How to use this E-Guidebook This E-Guidebook holds information that will enable you to: 1. Determine the countries in which you intend to market and/or sell your products It is essential to map out, at an early stage, the target countries in which you plan to enter. This would assist you in the creation of a comprehensive file for ICM and prevent future duplicative course of action. 2. Understand the conformity requirements of your target country(s) It is important to understand the requirements of each target country as local requirements can differ greatly from country to country. The key entry requirements of each country are detailed in this E-Guidebook. Please note that where “Manufacturer” is used, it typically represents manufacturers, importers and distributors of products that are to enter the target country. 3. Identify the conformity requirements that apply to your unique product This step is a challenging one due to the complex nature of the global regulatory framework – one or a combination of regulatory requirements may apply depending on the product. An in-depth knowledge of country-specific regulations, on top of a thorough understanding of your unique product, is crucial. Thus, partnering an ICM expert would be of great benefit in identifying the conformity requirements and standards that apply to your product. Global Market Access 4. Identify the necessary data and procedures that is required as part of the application Documentation and application procedures may vary depending on the type of compliance that is required by the country requirement and/or product. This E-Guidebook equips you with the fundamental information that you will need to complete the application. Nonetheless, engaging the assistance of a worthy ICM partner would ensure that the preparation process is structured and uncomplicated. 5. Recognize how TÜV SÜD is willing and able to help as an ICM partner With its one-stop ICM solutions, TÜV SÜD is a worthy partner that can provide you with all the necessary information and expertise for your quick access to global markets. Where accreditations are mentioned, please note that they are held by various subsidiaries of TÜV SÜD Group. Refer to TÜV SÜD Group to know more about TÜV SÜD. Where to Obtain More Information This E-Guidebook attempts to consolidate the key requirements of countries spanning across 6 regions for the ease and convenience of its readers. Please note that all reasonable measures have been taken to ensure the quality, reliability, and accuracy of the information in this E-Guidebook. However, country requirements are constantly changing and therefore information presented may possibly be incomplete or inaccurate. 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 9 Quick Access to Global Markets 01 03 Application of the E-Guidebook to Global Market Access The information in this E-Guidebook will be updated annually so as to keep with the ever-changing global regulatory framework. For more information, please email us at: ICM@tuev-sued.com Disclaimer This E-Guidebook is intended to provide general information on a particular subject or subjects and is not an exhaustive treatment of such subject(s). Accordingly, the information in this E-Guidebook is not intended to and shall not constitute consulting or professional advice or services. If you are seeking specific advice on any matters relating to information in this E-Guidebook, you should – where appropriate – contact us directly with your specific query or seek advice from qualified professional people. The accreditations mentioned in this E-guidebook are held by the various subsidiaries of TÜV SÜD. TÜV SÜD makes no representations or warranties, express or implied, about the information contained in this E-Guidebook, which are provided “as is”. Under no circumstances, including negligence, shall TÜV SÜD be held liable for any direct, indirect, incidental, special or consequential damages or expenses whatsoever arising out of or in connection with the use of this E-Guidebook or for any information contained herein, even if advised of the possibility of such damages. Global Market Access Copyright The copyright in this E-Guidebook belongs to TÜV SÜD. The information contained in this E-Guidebook may not be copied, quoted or referred to in any other publication or materials without the prior written consent of TÜV SÜD. All rights reserved © 2010 TÜV SÜD Asia Pacific Pte Ltd. 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 10 Quick Access to Global Markets 04 Country Regulations European Union (EU) 01 General Specifications Voltage230V Frequency 50Hz Manual Language Various languages depending on country European Economic Area (EEA) Countries* EU Countries Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Spain Sweden United Kingdom EFTA Countries Iceland Liechtenstein Norway Switzerland** * The EU has a relationship with the EFTA (European Free Trade Association) member countries through the Agreement of the EEA. The EEA enables EFTA to participate in the EU Single Market. **Although Switzerland is currently not part of EEA, it has a set of bilateral agreements with the EU. Thus, the proof of the overall safety of a product is identical to that of the EU. EU Conformity Requirements Category Regulatory Agency Regulations European Commission (EC) CE Marking1, according to EU Directives, is mandatory. DoC is sufficient but certification is recommended for marketing. Product safety testing is required. Compliance with European EN standards. Electrical Safety EC EMC 1 2 CE Marking according to EMC Directive. Guidelines CE Marking Procedure: 1. Identify the directives that apply to the product. If more than one applies, all must be complied with. 2. Determine the extent to which the product complies with the requirements of the applicable directive(s). 3. Choose the conformity assessment procedure2 based on the directive for your product. Global Market Access 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview CE Marking is not a certification, approval or quality mark, but a manufacturer’s declaration that the product meets the essential requirements of the respective directives. Most EU Directives require CE Marking. Conformity Assessment Procedure options for products with minimal risk include DoC while products with greater risks may require tests, audits or additional certificates from a Notified Body. 11 Quick Access to Global Markets 01 04 Country Regulations European Union (EU) Global Market Access 02 International Compliance Management EU Conformity Requirements Category Regulatory Agency Regulations EC CE Marking according to telecoms and wireless Directives. DoC is sufficient for harmonized standards; but where there is lack of harmonized standards, it is necessary for manufacturers to engage a Notified Body3. Telecoms & Wireless EC CE Marking according to medical devices directive is required. EC Energy Efficiency: Energy-related Products (ErP) Directive has repealed the Energy-using Products (EuP) Directive extending the scope of eco-design requirements to all ErPs. EC is still reviewing its effectiveness. For product categories with regulations in force, CE marking applies. RoHS & WEEE: Not CE Marking Directives but products must comply with RoHS & WEEE Directives, where applicable. Manufacturers must register compliance in target countries. 3 CE Marking Procedure: 4. Select the applicable product standards and test methods for your product and select an independent laboratory if the directive(s) states that product testing is to be done externally. 5. Compile the Technical File of technical documentation for your product. Medical Device Environmental Guidelines Notified bodies are organizations that have been accredited by EU Member States to serve as independent test laboratories to access whether products meet the requirements of product directives. They must have the necessary qualifications to meet the testing requirements set forth in the directives. The Technical File holds information that verifies that the testing was conducted properly and that the product complies with applicable standards; it is product dependent. 6. Prepare a DoC declaring that the product fulfils the requirements of the applicable directive(s) with the legally binding signature of the manufacturer. 7. Affix the CE Marking to your product. There are specific rules to adhere to in CE Marking. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 12 Quick Access to Global Markets 01 04 Country Regulations European Union (EU) Global Market Access 02 International Compliance Management Applicable Product Categories Product categories requiring CE Marking include: • • Toys Gas appliances • • Electrical products Cableway equipment • • Medical devices Telecommunications equipment A full list of product categories may be found at http://www.newapproach.org/Directives/DirectiveList.asp Application of the Guidebook Product groups with regulations according to ErP Directive include: • • • Simple set-top boxes External power supplies Circulators • • • Consumer electronics (televisions) Tertiary sector lighting Household refrigerating appliances • • • Standby and off-mode losses Electric motors Non-directional household lamps To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with EU4 (and individual country) requirements and obtaining the necessary approvals. The TÜV SÜD family is a Notified Body with the expertise and capability to test to a large variety of Directives. TÜV SÜD can provide: • • • • • 4 5 03 Expert opinions in the compliance of CE Marking requirements Test reports to support the Technical File documentation Assistance in completing the Technical File with diagrams, specifications, photographs, etc. CE Marking Certification of Conformity5 for safety, EMC, energy efficiency, RoHS & WEEE 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview EU Directives are the minimum requirements that manufacturers must meet for products to enter the EU. However, individual country requirements may also be present. On top of the CE Marking, which is simply a symbol for trade with the assumption of conformity, TÜV SÜD Marks are a certification of compliance with European (EN) standards. 13 Quick Access to Global Markets 04 Country Regulations Russia General Specifications Voltage Frequency Manual Language 220V (Single Phase); 380V (Three Phase) 50Hz Russian/English Regulatory Agency Regulations Federal Agency on Technical Regulating and Metrology Products* may be subject to one or a combination of mandatory approval systems. GOST-R approval is most commonly required for almost all products. CoC is mandatory for regulated products. For some products not under mandatory certification, a DoC is required instead. Products must be marked with the GOST-R Mark. A local representative is required for DoC. Testing must be performed by accredited test labs and certification may only be obtained from accredited CBs. Compliance with national GOST standards. EMC: EMC compliance is required for the above, where applicable. 2. Factory inspection Electrical Safety Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. Global Market Access 02 International Compliance Management Russia Conformity Requirements Category 01 Guidelines GOST-R Certification may be obtained for serial production or single delivery, where applicable. Conformity Assessment includes: 1. Submission of application, test reports and essential documentation 3. Quality Management System certification (where applicable) For certain products, the SanitaryEpidemiological Conclusion Certificate** is required as a pre-requisite for GOST-R approval to confirm compliance with hygienic standards. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Malaysia requirements and obtaining the necessary approvals. As a listed testing laboratory for Malaysia under the ASEAN EE MOU. TÜV SÜD’s test reports are accepted by ST for safety approval. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview As of 2010, there are 16 mandatory certification systems regulated by Russian Laws. Apart from the above-mentioned approvals, regulated products may also require other mandatory approvals. Approvals for different scopes are granted by different Russian Ministries. ** The Sanitary-Epidemiological Conclusion Certificate is only issued by the Russian Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection, Rospotrebnadzor. It is required for food stuff, food or skin – related products and children’s products. * 14 Quick Access to Global Markets 01 04 Country Regulations Russia Global Market Access 02 International Compliance Management Russia Conformity Requirements Category Regulatory Agency Regulations Federal Agency of Communications (FAC) Products* may be subject to one or a combination of mandatory certification systems. FAC approval is required for most telecoms and wireless equipment. CoC is required for equipment under mandatory certification, and may only be obtained from accredited CBs. For equipment not under mandatory certification, a DoC is required. EMC: EMC compliance is required for the above, where applicable. Telecoms & Wireless Applicable Product Categories Approval is mandatory for radio transmitter devices and telecoms terminal devices. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Russia requirements and obtaining the necessary approvals. * Guidelines A local representative is required for DoC. Evaluation procedures may include: 1. Documentary audit 2. Surveillance visits 3. Sample testing in accredited laboratories 4. Factory audits Additional RF import permit must be obtained from the GKRCH or Ministry of Trade and Industry (MINPROMTORG), depending on the product. Encryption notifications should also be declared to Federal State Security Service (FSB) before import of RF products. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview As of 2010, there are 16 mandatory certification systems regulated by Russian Laws. Apart from the above-mentioned approvals, regulated products may also require other mandatory approvals. Approvals for different scopes are granted by different Russian Ministries. 15 Quick Access to Global Markets 01 04 Country Regulations Russia Global Market Access 02 International Compliance Management Russia Conformity Requirements Category Medical Device Regulatory Agency Regulations Federal Service for Control over Healthcare and Social Development, Roszdravnadzor Products may be subject to one or a combination of mandatory certification systems*. Medical devices are required to obtain registration certificate. Class 1 and 2a devices with a clearly identified equivalent device already registered in Russia must demonstrate its similarity to the predicate. For Class 1 and 2a devices with a registered equivalent and all Class 2b and 3 devices must be tested incountry. To clear through customs, devices must also have either the Sanitary-Epidemiological Conclusion or the GOST-R approval, or both, where applicable (see Electrical Safety). Guidelines A local representative is usually required. Where testing is required, devices must be tested to Russian standards regardless of whether the device already has US 510(k) clearance, EU CE Marking or other national approvals. Registration certificate will be issued upon submission of satisfactory registration dossier. Device classification is similar to that in Europe. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Russia requirements and obtaining the necessary approvals. * As of 2010, there are 16 mandatory certification systems regulated by Russian Laws. Apart from the above-mentioned approvals, regulated products may also require other mandatory approvals. Approvals for different scopes are granted by different Russian Ministries. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 16 Quick Access to Global Markets 01 04 Country Regulations Russia Global Market Access 02 International Compliance Management Russia Conformity Requirements Category Regulatory Agency Regulations Federal Agency on Technical Regulating and Metrology Energy Efficiency: Minimum Energy Performance Standards (MEPS) and energy efficiency labelling are available and voluntary. Guidelines All imported household appliances and those produced in Russia need to have energy efficiency label starting from 2011 Environmental Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Russia requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 17 Quick Access to Global Markets 04 Country Regulations Argentina General Specifications Voltage Frequency Manual Language 220V (Single Phase); 380V (Three Phase) 50Hz Spanish Regulatory Agency Regulations Electrical Safety Secretariat of Industry, Commerce and Mining & Instituto Argentino de Normalización y Certificación (IRAM) In accordance with Resolution 92/98, products to be sold in the domestic market are required to be certified by an organization accredited by the Argentine Accreditation Body and recognized by the national authorities. The mandatory S-Mark signifies that a product has been certified by an organization accredited and authorized by the authorities. Global Market Access 02 International Compliance Management Argentina Conformity Requirements Category 01 Guidelines Manufacturers need to apply to IRAM and submit essential documents for safety approval. Testing should be conducted to IEC standards for electrical and electronics equipment. Initial and annual factory inspections are required for safety certification. Compliance with IEC standards. Applicable Product Categories All devices, apparatus or electrical materials intended to be used by consumers rated between 50V and 1000Vac or 1500Vdc require mandatory certification. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Argentina requirements and obtaining the necessary approvals. TÜV SÜD can provide CB test reports that are accepted for safety approval through its MOU with IRAM. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 18 Quick Access to Global Markets 01 04 Country Regulations Argentina Global Market Access 02 International Compliance Management Argentina Conformity Requirements Category Regulatory Agency Regulations Comisión Nacional de Comunicaciones (CNC) Testing and approval is required for most telecommunication line terminal equipment and radio frequency equipment. Approval may be in 2 forms – Homologación (approval to Argentina standard) or Codificación (accepted approval for which no standard exists). *Testing of equipment must be performed by accredited in-country test labs. Approval certification must be obtained from CNC. Telecoms & Wireless Guidelines A local representative is required. The Argentina importer or distributor must be registered with CNC in order to obtain the certificate. Approved equipment will be listed in the Register of Telecommunication Equipment and Activities. Applicable Product Categories Approval is required for: • All terminal equipment to be connected to the public telephone network • Most radio equipment • Low-power spread-spectrum products operating in the 2.4–2.4835 GHz band To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Argentina requirements and obtaining the necessary approvals. * Although foreign test reports are not accepted, they may speed up the approval process. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 19 Quick Access to Global Markets 01 04 Country Regulations Argentina Global Market Access 02 International Compliance Management Argentina Conformity Requirements Category Regulatory Agency Regulations Medical Device National Administration of Drugs, Foodstuffs and Medical Technology (ANMAT), Ministry of Health The domestic manufacture or importation of medical products into the Argentine market must be registered with ANMAT, in conformity with MERCOSUR Technical Regulations for Registration of Medical Products. All medical devices are required to meet the essential requirements in disposition 4306/99. Good Manufacturing Practice (GMP) for medical devices should be applied and certified according to disposition 191/99. A DoC with the MERCOSUR legislation is required for all devices. A Certificate of Free Sale is also required for Class II, III and IV devices. A risk analysis and clinical trials are also required for class III and IV devices. Guidelines An office or a local distributor in Argentina registered with the Ministry of Health is required. Manufacturers are required to submit technical information with the registration, including documents that are legalized by the Argentine Consulate or Embassy in the product’s country of origin. Devices are divided based on the level of risk, into Class I, II, III and IV, with Class IV representing the highest risk. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Argentina requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 20 Quick Access to Global Markets 01 04 Country Regulations Argentina Global Market Access 02 International Compliance Management Argentina Conformity Requirements Category Regulatory Agency Regulations Secretariat of Industry, Commerce and Mining Energy Efficiency: To be marketed in Argentina, household appliances within the scope of Resolution 319/99 must include a label stating their energy consumption level, to be determined using test methods indicated in the applicable IRAM standard. Environmental Guidelines The law requires the information to be provided in a brochure, which must be included with the instruction manual. Efficiency is rated from A to G, A being the most efficient. Applicable Product Categories Product categories that require mandatory labelling include: • Refrigerators • Washing machines • Freezers • Dryers • Fluorescent ballasts • Dishwashers • Fluorescent lamps • Air-conditioners To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Argentina requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 21 Quick Access to Global Markets 04 Country Regulations Brazil General Specifications Voltage Frequency Manual Language 127V / 220V (Single Phase); 220V / 380V (Three Phase) 60Hz Portuguese Electrical Safety Regulatory Agency Regulations National Institute of Metrology, Standardization and Industrial Quality (INMETRO) Mandatory testing and certification is required for certain regulated product categories. Testing must be performed by a Product Certification Body that is accredited by INMETRO. Initial and follow-up factory inspections are required for mandatory certification. Products certified by an INMETRO-accredited body are required to carry the mandatory INMETRO Mark of the certification organization. Compliance with ABNT, NBR, NM and/or IEC standards. Guidelines The INMETRO Mark can be applied to products under both mandatory and voluntary certification lists. Generally, testing must be performed in-country. According to Decree 371, household and similar electric appliances to be sold in Brazil will be on the Compulsory INMETRO Certification List starting from July 1, 2011. Applicable Product Categories Product categories that require mandatory certification include: • Switches • Plugs and sockets • Wires and cables • Circuit breakers • Electro medical equipment • Explosive atmosphere equipment • Voltage stabilizers • Electronic ballasts for fluorescent lights Global Market Access 02 International Compliance Management Brazil Conformity Requirements Category 01 • Equipment for gas systems To determine if a particular product is subject to the above regulations, please Contact Us. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Brazil requirements and obtaining the necessary approvals. 22 Quick Access to Global Markets 01 04 Country Regulations Brazil Global Market Access 02 International Compliance Management Brazil Conformity Requirements Category Regulatory Agency Regulations Agência Nacional de Telecomunicações (ANATEL) Approval is required for most Telecoms and Wireless equipment. CoC issued by designated CB (OCD) is required for imports, and ANATEL certification is required for commercialization and sale of products. Modular approval is accepted for RF. Testing must be performed by accredited in-country test labs. Telecoms & Wireless Guidelines A local representative is required. Conformity assessment to Brazilian standards is required to be performed by accredited CABs. Approval requirements may differ depending on which 1 of the 3 categories the equipment is assigned to. Type examination, product quality assurance, and total quality assurance may be performed. Applicable Product Categories Approval is required for: • All telecommunication terminal equipment • All network equipment • A wide range of radio products • All equipment connecting to Integrated Services Digital Network (ISDN) • All DLL (E1, E3, etc.) equipment • All optical interfaces To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Brazil requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 23 Quick Access to Global Markets 01 04 Country Regulations Brazil Global Market Access 02 International Compliance Management Brazil Conformity Requirements Category Regulatory Agency Regulations Medical Device Brazilian National Health Surveillance Agency, Agencia Nacional Vigilancia de Sanitaria (ANVISA) All medical devices intended for sale in Brazil must be registered with ANVISA. Manufacturers must also prove compliance with Good Manufacturing Processes (GMP). For mandatory testing of regulated products, testing must be performed by accredited test labs. Guidelines An import license is required for registration. 03 Documentation to be submitted is to a large extent compliant with the Global Harmonization Task Force Guidance (GHTF) for Summary Technical Documentation (STED). 04 Medical device classification in Brazil is similar to that of the US FDA and the EU medical device directive. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Brazil requirements and obtaining the necessary approvals. Application of the Guidebook Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 24 Quick Access to Global Markets 01 04 Country Regulations Brazil Global Market Access 02 International Compliance Management Brazil Conformity Requirements Category Environmental Regulatory Agency Regulations National Institute of Energy Efficiency: Metrology, Standardization Minimum Energy Performance Standard (MEPS) are and Industrial Quality required for some products. (INMETRO) Mandatory energy efficiency labelling is required for certain products Guidelines PROCEL is the national energy efficiency program and INMETRO is responsible for verifying manufacturers’ data. Applicable Product Categories Product categories that require mandatory labelling include: • Freezers • Refrigerators • Air conditioners • Compact fluorescent lamps • Clothes washers To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Brazil requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 25 Quick Access to Global Markets 04 Country Regulations Canada General Specifications Voltage Frequency Manual Language 120V (Single Phase); 208V / 240V / 600V (Three Phase) 60Hz English/French Electrical Safety Regulatory Agency Regulations Standards Council of Canada (SCC) & Authorities Having Jurisdiction (AHJ)* Certification must be obtained from an SCC accredited CB. Safety testing is mandatory and factory inspections are required, where applicable. Compliance with CSA, UL and/or IEC standards. Guidelines Although certification is not mandatory, it is highly recommended for marketing purposes, while offering state-level authorities a sound basis for product evaluation. Certified products are “Marked” by the manufacturer with the mark of the SCC accredited CB. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Canada requirements and obtaining the necessary approvals. As a SCC accredited CB, TÜV SÜD can provide electrical safety certification, with the TÜV SÜD NRTL mark, for a range of products including: • Laboratory equipment • Industrial control systems • Electrical drives • IT equipment • Power Supplies • Laser * Global Market Access 02 International Compliance Management Canada Conformity Requirements Category 01 AHJs are local jurisdictions and include the provincial or state governor, city of town mayor, building official, contracted agency or building inspector. AHJs may have additional local requirements. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 26 Quick Access to Global Markets 01 04 Country Regulations Canada Global Market Access 02 International Compliance Management Canada Conformity Requirements Category Regulatory Agency Regulations Industry Canada (IC) Conformity assessment is subject to the DoC process. The testing and certification of Radio Apparatus by a recognized CB is required. Guidelines A local representative is required. DoC Procedure: 1. Test the equipment to verify compliance at an accredited test lab Telecoms & Wireless IC Manufacturers’ declaration is required for certain products according to ICES standards. EMC Applicable Product Categories A full list of applicable telecoms equipment may be found at http://www.ic.gc.ca/eic/site/ceb-bhst.nsf/ eng/h_tt00046.html A full list of applicable radio equipment may be found at http://www.ic.gc.ca/eic/site/ceb-bhst.nsf/eng/h_ tt00061.html To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Canada requirements and obtaining the necessary approvals. TÜV SÜD is a Foreign CB, appointed under the EU-Canada MRA, to issue IC Type Acceptance Certificates for all Radio equipment in the Category 1 equipment list. 2. Keep a compliance folder on file 3. Affix the equipment with the registration number and model identification number as stated in the requirements 4. Register the equipment with the Bureau through E-filing and add the equipment to IC’s Terminal Equipment List Certification Procedure: Manufacturers must use an IC recognized CB. Certified equipment should be labelled in accordance with IC labelling requirements. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 27 Quick Access to Global Markets 01 04 Country Regulations Canada Global Market Access 02 International Compliance Management Canada Conformity Requirements Category Regulatory Agency Regulations Health Canada A specific quality systems standard, ISO 13485, is required for Class II, III and IV medical devices as a prerequisite to obtaining device licensing. Only an ISO 13485 certificate issued by an SCCqualified CMDCAS* Registrar will be accepted. Medical Device Guidelines Manufacturers must submit the appropriate certificate with their annual renewal applications. Requirements involve both an off-site document review and an on-site audit. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Canada requirements and obtaining the necessary approvals. As a SCC qualified CMDCAS Registrar, TÜV SÜD is competent to perform audits of medical device manufacturers and issue registration certificates to satisfy the regulations. * CMDCAS refers to the Canadian Medical Devices Conformity Assessment System. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 28 Quick Access to Global Markets 01 04 Country Regulations Canada Global Market Access 02 International Compliance Management Canada Conformity Requirements Category Regulatory Agency Environmental Regulations National Resources Canada Energy Efficiency: Minimum Energy Performance (NRCan) Standard (MEPS) are required for many products. Mandatory EnerGuide Program labelling is required for certain products. WEEE: Manufacturer’s declaration to WEEE programs per province. Guidelines Canada’s EnerGuide labelling requirements are coordinated with the US EnergyGuide labelling program Applicable Product Categories Product categories that require mandatory EnerGuide labelling include: • Wine chillers • Freezers • Refrigerators • Clothes washers • Clothes dryers • Cooktops and Ranges/ Ovens • Room air conditioners A full list of product categories may be found at http://www.apec-esis.org/countrysummary.php?country=Canada&ID=247 To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Canada requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 29 Quick Access to Global Markets 04 Country Regulations Mexico General Specifications Voltage Frequency Manual Language 127V (Single Phase); 220V / 480V (Three Phase) 60Hz Spanish Regulatory Agency Regulations Secretariat of Commerce and Industrial Promotion (SECOFI) Manufacturers are required to obtain NOM Certification for regulated products. Electrical Safety Information Technology equipment, household appliances and medical equipment, domestic or imported, must meet NOM requirements. Testing must be performed by an accredited Mexican testing laboratory or a laboratory outside of Mexico that has a MRA with an accredited Mexican laboratory Global Market Access 02 International Compliance Management Mexico Conformity Requirements Category 01 Guidelines A local representative is required. Essential documentation need to be submitted to the CB for certification. Post-market surveillance after obtaining certification is required. Applicable Product Categories The NOM regulation applies to Information Technology equipment, household appliances and specific medical equipment. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Mexico requirements and obtaining the necessary approvals. TÜV SÜD IECEE-CB test reports are accepted for Mexico safety approval through SEATSA-TÜV SÜD PSB MOU. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 30 Quick Access to Global Markets 01 04 Country Regulations Mexico Global Market Access 02 International Compliance Management Mexico Conformity Requirements Category Regulatory Agency Regulations Comisión Federal de Telecomunicaciones (COFETEL) All products that use a frequency to transmit and/or receive signals and all telecom products that connect to the PSTN or public network must be certified by COFETEL. Where no existing standards apply, manufacturers are required to apply for provisional approval (for first-time application) before permanent approval. Foreign test reports are accepted for analysis for provisional approval but testing of equipment for permanent approval must be performed in-country. Where NOM standards apply to products, in-country testing is also required. Telecoms & Wireless Guidelines A local representative is required. To obtain approval, manufacturers require an in-country Mexico NOM safety certificate holder. For provisional and permanent approval, test reports and essential documentation should be submitted in the application package to COFETEL. For products which NOM standards apply, no permanent certification is required as they are subject to random follow-up verification testing. Applicable Product Categories Approval is required for: • All terminal equipment connecting to the public telecom network including DLL and ISDN • All radio equipment including most digital products To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability able to support manufacturers in attaining compliance with Mexico requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 31 Quick Access to Global Markets 01 04 Country Regulations Mexico Global Market Access 02 International Compliance Management Mexico Conformity Requirements Category Regulatory Agency Regulations Secretariat of Health, Ministry of Health To be imported into Mexico, all medical or health care products that touch the human body must be registered with the Mexican Secretariat of Health. ISO 13485 certificate or official proof of compliance with US FDA GMP or another national quality system standard is required for all devices except some Class I devices. Certain medical electrical devices must undergo testing to obtain NOM Mark certification. Clinical data and biocompatibility testing is required for Class III devices. Medical Device Guidelines A local representative is required. Manufacturers need to submit a registration dossier to the Secretariat. Upon issuance of certificate, confirmation of the completed registration will be posted on the Ministry of Health website. Medical devices are classified into 3 classes of increasing risk – Class 1, 2 and 3. Applicable Product Categories This registration is required for wound care materials, surgical devices or material, hygienic products, dentistry products, family planning products, implantable prosthesis, diagnostic agents, reagents, medical equipment and instruments, external prosthesis, orthosis and functional aids. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Mexico requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 32 Quick Access to Global Markets 01 04 Country Regulations Mexico Global Market Access 02 International Compliance Management Mexico Conformity Requirements Category Environmental Regulatory Agency Regulations Comisión Nacional para el Energy Efficiency: Ahorro de Energia (CONAE), Minimum Energy Performance Standard (MEPS) are Energy Secretariat required for some products. Mandatory energy efficiency labelling is required for certain products. Guidelines Products are rated based on the percentage of energy savings relative to the MEPS level, according to NOM standards. Applicable Product Categories Product categories that require mandatory labelling include: • Freezers • Refrigerators • Air conditioners • Water heaters • Clothes washers To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Mexico requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 33 Quick Access to Global Markets 04 Country Regulations United States of America (USA) General Specifications Voltage Frequency Manual Language 120V (Single Phase); 120/208V / 277/480V (Three Phase) 60Hz English Regulatory Agency Regulations Electrical Safety Occupational Safety and Health Administration (OSHA) & Authorities Having Jurisdiction* (AHJ) Specific categories of materials/equipment (products) are required to be approved by a OHSA Nationally Approved Test Laboratory (NRTL) per provisions of the General Industry Standards (Part 1910 of Title 29, Code of Federal Regulations - 29 CFR Part 1910) Factory inspections are required. Compliance with UL and/or IEC standards. Global Market Access 02 International Compliance Management USA Conformity Requirements Category 01 Guidelines Certified products are “Marked” by the manufacturer with the mark of the NRTL and listed in a “Listing Book” published by the NRTL. 03 Application of the Guidebook 04 To determine if a particular product is subject to the above regulations, please Contact Us. Country Regulations Africa Asia Pacific Europe Middle East NAFTA TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with USA requirements and obtaining the necessary approvals. 05 Applicable Product Categories A full list of product categories may be found at http://www.osha.gov/dts/otpca/nrtl/prodcatg.html As a recognized NRTL, TÜV SÜD can provide electrical safety certification for a range of products including: • Laboratory equipment • Industrial control systems • Electrical drives • IT equipment • Power Supplies • Laser etc. Go to: http://www.osha.gov/dts/otpca/nrtl/tuvpsg.html for the complete scope of NRTL services offered by TÜV SÜD. * TÜV SÜD Group 06 Quick Reference Overview AHJs are local jurisdictions and include the provincial or state governor, city of town mayor, building official, contracted agency or building inspector. AHJs may have additional local requirements. 34 Quick Access to Global Markets 01 04 Country Regulations United States of America (USA) Global Market Access 02 International Compliance Management USA Conformity Requirements Category Regulatory Agency Regulations Administrative Council for Terminal Attachments (ACTA) CFR Part 68 requires compliance. Declaration of Compliance (DoC) is required. Telecoms Wireless Guidelines DoC Procedure: 1. Test the product for compliance at an accredited test lab 2. Prepare a technical file Federal Communications Commission CFR Part 15 requires compliance. Testing by an accredited test lab is required. (FCC) DoC or Certification from a Telecoms CB is required. As a general guide: • DoC or Certification for unintentional radiators • Certification for intentional radiators 3. Mark the product and place the requirement FCC notices in the user manual 4. Prepare and sign a DoC Certification Procedure: 1. Get the product tested at a Telecoms CB 2. Submit the test report, together with other essential documents and a proposed FCC ID Number to the FCC 3. Mark the product with the FCC ID and compliance statement, and place the required FCC notices in the user manual 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 35 Quick Access to Global Markets 01 04 Country Regulations United States of America (USA) Global Market Access 02 International Compliance Management USA Conformity Requirements Category Regulatory Agency Regulations FCC Manufacturers’ declaration is required for certain products stated in Title 47 of the CFR, Part 15 and Part 18. Household appliances are exempted. EMC Guidelines DoC Procedure: 1. Test the product for compliance at an accredited test lab 2. Prepare a technical file 3. Mark the product and place the requirement FCC notices in the user manual Applicable Product Categories Common unintentional radiators include personal computers, peripherals, receivers, radios, TV sets, and cable TV home terminals. 4. Prepare and sign a DoC Intentional radiators include cable-locating equipment, cordless telephones, remote control and alarm transmitters, field-disturbance sensors for opening doors, and spread-spectrum systems for wideband data transmission. 1. Get the product tested at a Telecoms CB To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with USA requirements and obtaining the necessary approvals. As a Telecoms CB, TÜV SÜD is authorised by the FCC to issue grants for a wide range of equipment within the following categories: • Unlicensed Radio Equipment Equipment • Licensed Radio Service • Radio Equipment (intentional and unintentional radiators) • Wireline Terminal Equipment Certification Procedure: 2. Submit the test report, together with other essential documents and a proposed FCC ID Number to the FCC 3. Mark the product with the FCC ID and compliance statement, and place the required FCC notices in the user manual 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 36 Quick Access to Global Markets 01 04 Country Regulations United States of America (USA) Global Market Access 02 International Compliance Management USA Conformity Requirements Category Regulatory Agency Regulations Food and Drug Administration (FDA) Medical devices distributed in the United Sates are subject to General Controls, pre-marketing and post marketing regulatory controls. Most Class I devices are exempt from premarket notification. Most Class II devices typically require submission of 510(k) clearance-to-market obtained from authorized institutions. Production site inspection is also required. Most Class III devices typically require Pre-Market Approval (PMA) submission. Manufacturers must also comply with quality system regulations/Good Manufacturing Practices. Medical Device Guidelines Manufacturers must register their establishments and list devices with FDA. 510(k): identifies characteristics of a new/ modified medical device compared with a medical device with similar intended use already marketed in USA. PMA: significant scientific review of the safety and effectiveness of the device. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with USA requirements and obtaining the necessary approvals. TÜV SÜD is authorized by the FDA under the Accredited Persons program to submit 510(k) applications on behalf of medical device manufacturers for all eligible Class I & II devices as well as provide Third-Party FDA Inspections. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 37 Quick Access to Global Markets 01 04 Country Regulations United States of America (USA) Global Market Access 02 International Compliance Management USA Conformity Requirements Category Regulatory Agency Regulations Environmental Protection Agency (EPA) Energy Efficiency: Minimum Energy Performance Standard (MEPS) are required for many products. Mandatory Energy Guide labelling is required for certain products. Energy Star: A voluntary certification initiative to motivate companies to develop energy efficient electrical products by offering various incentives. RoHS: Californian RoHS under the Electronic Waste Recycling Act 2003. Environmental Guidelines Manufacturers must submit energy use data to the DOE and EPA stating that it complies with the regulations. They must also report to DOE and EPA when a new model is introduced or an existing one discontinued. Information on EnergyGuide labels must be based on Department of Energy (DOE) test procedures. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 Applicable Product Categories Product categories that require mandatory EnergyGuide labelling include: • Dishwashers • Fluorescent lamps • Water heaters • Heaters • Clothes washers • Heat pumps • Freezers • Central air conditioners • Room air conditioners • Refrigerators • Furnaces • Ballasts • Boilers A full list of product categories may be found at http://www.apec-esis.org/countrysummary.php?country=USA&ID=262 To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Group 06 Quick Reference Overview TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with USA requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 38 Quick Access to Global Markets 04 Country Regulations Australia General Specifications Voltage Frequency Manual Language 240V (Single Phase); 415V (Three Phase) 50Hz English Electrical Safety Regulatory Agency Regulations NSW Fair Trading & Electrical Regulatory Authorities Council (ERAC) Products are classified as either declared or nondeclared articles. Declared articles must comply with safety standards and obtain approval in one of the following ways: • Certificate of Approval (CoA) from a State/Territory authority and appropriate marking; or • Regulatory Compliance Mark (RCM) from accredited Certification Office Manufacturers may also obtain other voluntary safety certification*. Non-declared articles do not require certification; a voluntary Certificate of Suitability (CoS) can be obtained. Manufacturers maintain full liability for the product’s safety and adherence to Australian standards. Compliance with AS/NZS and/or IEC standards. Global Market Access 02 International Compliance Management Australia Conformity Requirements Category 01 Guidelines By interstate agreement and legislation, a safety certificate issued by the appropriate regulatory authority in any State/Territory is recognized across Australia and New Zealand**. Test report should be from a test lab accredited by the National Association of Testing Authorities (NATA) or another lab approved by the regulator. CoA only covers product safety while RCM covers both safety and EMC requirements (where applicable). Applicable Product Categories There are 56 classes of electrical items classified as declared articles. Examples include dishwashers, hairdryers, room heaters and sewing machines. A full list of product categories may be found at http://www.fairtrading.nsw.gov.au/pdfs/Businesses/Explanatory_notes_and_declaring_order.pdf To determine if a particular product is subject to the above regulations, please Contact Us. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Australia requirements and obtaining the necessary approvals. As a designated RAB under MRA with Australia, TÜV SÜD can issue CoC for to expedite approval from State/Territory authority. * ** Voluntary safety certification such as the Standards Mark and Type Examination Certificate can be obtained from accredited Australia COs. CoA or RCM applied in Australia also indicates similar compliance in New Zealand, vice versa. 39 Quick Access to Global Markets 01 04 Country Regulations Australia Global Market Access 02 International Compliance Management Australia Conformity Requirements Category Regulatory Agency Regulations Telecoms Australian Communications Products are classified into 3 levels depending on the & Media Authority (ACMA) degree of impact non-compliance has on the safety of persons or the integrity of a telecommunications network or facility – Level 1 having limited impact and Level 3 having risk of adverse impact. Manufacturers are required to sign a DoC and hold a product description. Regulated products should also be affixed with the A-Tick Mark. Guidelines A local representative is required to apply to use the A-Tick Mark. Manufacturers of Level 2 and 3 products are also required to hold a test report or Technical Construction File. The test report for Level 3 products must be from a properly accredited test lab. Applicable Product Categories A full list of product categories under telecoms standards may be found at http://www.acma.gov.au/WEB/STANDARD/pc=PC_2545 To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Australia requirements and obtaining the necessary approvals. TÜV SÜD can also perform required testing to applicable standards. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 40 Quick Access to Global Markets 01 04 Country Regulations Australia Global Market Access 02 International Compliance Management Australia Conformity Requirements Category Wireless & EMC* Regulatory Agency Regulations Australian Communications Products are classified into 3 levels depending on the & Media Authority (ACMA) degree of impact of its interfering emissions to devices using the radio frequency spectrum – Level 1 being low impact and Level 3 being highest risk of serious impact. Manufacturers are required to sign a DoC and hold a product description. Regulated products should also be affixed with the C-Tick Mark. The RCM can also be used to indicate EMC compliance. Guidelines A local representative is required to apply to use the C-Tick Mark. Manufacturers of Level 2 and 3 products are also required to hold a test report or Technical Construction File. The test report for Level 3 products must be from a properly accredited test lab. Applicable Product Categories A full list of product categories under wireless standards may be found at http://www.acma.gov.au/WEB/STANDARD/pc=PC_100095 A full list of product categories under EMC standards may be found at http://www.acma.gov.au/WEB/STANDARD/pc=PC_310707 To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Australia requirements and obtaining the necessary approvals. TÜV SÜD can also perform required testing to applicable standards. * Wireless and EMC requirements are similar in Australia and New Zealand; the approvals applied in Australia also indicate similar compliance in New Zealand, vice versa. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 41 Quick Access to Global Markets 01 04 Country Regulations Australia Global Market Access 02 International Compliance Management Australia Conformity Requirements Category Medical Device Regulatory Agency Regulations Department of Health and Ageing Manufacturers are required to apply to include devices in the Australian Register of Therapeutic Goods (ARTG). All manufacturers of Class I (non-sterile and nonmeasuring) devices need to prepare a DoC and obtain a Certificate of Inclusion in the ARTG. Australian manufacturers of devices that fall in classes other than Class I (non-sterile and non-measuring), and foreign manufacturers of Class III and Class AIMB devices, require a Conformity Assessment Certificate from TGA and a DoC in order to be included in the ARTG. Foreign manufacturers of devices that fall in classes other than the above-mentioned – Class I (non-sterile and non-measuring), Class III and Class AIMD – require conformity assessment evidence from the TGA or an EU Notified Body, and a DoC, in order to be included in the ARTG. Therapeutic Goods Administration (TGA) Guidelines A local representative is required. The classification of a medical device determines the conformity assessment procedures manufacturers can choose to ensure that the device is adequately assessed. Higher classification devices must undergo more stringent conformity assessment procedures than lower classification devices. The conformity assessment procedures have been modelled on those developed by the Global Harmonization Task Force (GHTF). Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Australia requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 42 Quick Access to Global Markets 01 04 Country Regulations Australia Global Market Access 02 International Compliance Management Australia Conformity Requirements Category Environmental Regulatory Agency Regulations Australian Greenhouse Office & State Agencies* Energy Efficiency: Minimum Energy Performance Standards (MEPS) are required for many products. Mandatory Star Rating Label Scheme is required for certain products. Guidelines Online registration applications must be made in the format as prescribed in the applicable Australian Standard. Applicable Product Categories A full list of product categories may be found at http://www.energyrating.gov.au/man1.html To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Australia requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. * In Australia, energy labelling and MEPS are controlled by State rather than national legislation. There are 4 regulators in Australia – in NSW, Queensland, South Australia and Victoria. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 43 Quick Access to Global Markets 04 Country Regulations New Zealand General Specifications Voltage Frequency Manual Language 240V (Single Phase); 415V (Three Phase) 50Hz English Regulatory Agency Regulations Electrical Safety Ministry of Economic Development, Energy Safety & Electrical Regulatory Authorities Council (ERAC) All products are required to comply with New Zealand standards. Products considered to have a medium to high safety risk require a Supplier Declaration of Compliance (SDoC). Products considered to have high safety risk are required to obtain approval in one of the following ways: • Certificate of Approval (CoA) by the Ministry (or other certification that is formally recognised by a Gazette Notice as an Approval); or • Regulatory Compliance Mark (RCM) from an accredited CB Compliance with AS/NZS and/or IEC standards. Global Market Access 02 International Compliance Management New Zealand Conformity Requirements Category 01 Guidelines By interstate agreement and legislation, a safety certificate issued by the appropriate regulatory authority in any State/Territory is recognized across New Zealand and Australia . Approvals are not required for products that have a recognized certification. Most listed products that are sold in Australia will already have a suitable recognised Australian Approval. Test report should be from a recognized test lab. CoA only covers product safety while RCM covers both safety and EMC requirements (where applicable). Applicable Product Categories A full list of product categories requiring SDoC may be found at http://www.energysafety.govt.nz/templates/ContentTopicSummary____27859.aspx A full list of product categories requiring Approval may be found at http://www.energysafety.govt.nz/templates/ContentTopicSummary____27858.aspx To determine if a particular product is subject to the above regulations, please Contact Us. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with New Zealand requirements and obtaining the necessary approvals. As a designated RAB under MRA with New Zealand, TÜV SÜD can issue CoC for to expedite approval from State/Territory authority. 44 Quick Access to Global Markets 01 04 Country Regulations New Zealand Global Market Access 02 International Compliance Management New Zealand Conformity Requirements Category Regulatory Agency Regulations Ministry of Economic Development A Telepermit indicates that a product may be connected to the Telecom New Zealand network. Testing should be performed by a Recognized Testing Authority according to Permit to Connect (PTC) specifications. Application should be submitted to Telecom New Zealand’s Access Standards Team. Upon being granted with Telepermit, manufacturers are required to label products appropriately. Telecoms Guidelines A local representative is required. Certification Procedure: 1. Submission of application, test report and essential documents 2.Assessment 3. Telepermit grant Applicable Product Categories A full list of product categories under telecoms standards may be found at http://www.telepermit.co.nz/resources_index.html To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with New Zealand requirements and obtaining the necessary approvals. TÜV SÜD can also perform required testing to applicable standards. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 45 Quick Access to Global Markets 01 04 Country Regulations New Zealand Global Market Access 02 International Compliance Management New Zealand Conformity Requirements Category Regulatory Agency Regulations Ministry of Economic Development, Radio Spectrum Management (RSM) Products are classified into 3 levels depending on the degree of impact of its interfering emissions to devices using the radio frequency spectrum – Level 1 being low impact and Level 3 being highest risk of serious impact. Manufacturers are required to sign a DoC and hold a product description. Regulated products should also be affixed with the C-Tick Mark. The RCM can also be used to indicate EMC compliance. Wireless & EMC* Guidelines A local representative is required to apply to use the C-Tick Mark. Manufacturers of Level 2 and 3 products are also required to hold a test report or Technical Construction File. The test report for Level 3 products must be from a properly accredited test lab. Applicable Product Categories A full list of product categories under wireless standards may be found at http://www.acma.gov.au/WEB/STANDARD/pc=PC_100095 A full list of product categories under EMC standards may be found at http://www.acma.gov.au/WEB/STANDARD/pc=PC_310707 To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with New Zealand requirements and obtaining the necessary approvals. TÜV SÜD can also perform required testing to applicable standards. * Wireless and EMC requirements are similar in Australia and New Zealand; the approvals applied in Australia also indicate similar compliance in New Zealand, vice versa. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 46 Quick Access to Global Markets 01 04 Country Regulations New Zealand Global Market Access 02 International Compliance Management New Zealand Conformity Requirements Category Regulatory Agency Regulations MEDSAFE, Ministry of Health Under current legislation, ministerial consent is not required for the distribution of medical devices. Medical devices are subject to the notification requirements set out in the Medicines (Database of Medical Devices) Regulations 2003. Manufacturers are required to enter details into the medical device database through Web Assisted Notification of Devices (WAND). Diagnostic devices for in-vitro use are exempt from notification requirements. All condoms and intra-uterine contraceptive devices distributed in New Zealand are required by law to comply with applicable standards. Medical Device Guidelines A local representative (also known as a sponsor) is required to make WAND notifications. WAND may be accessed from the MEDSAFE website. The notification of a device to the WAND database does not constitute approval or endorsement of the safety or efficacy of a medical device by MEDSAFE or any other regulatory body. Registration of medical devices is expected to become a legal requirement in the future under proposed legislation. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with New Zealand requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 47 Quick Access to Global Markets 01 04 Country Regulations New Zealand Global Market Access 02 International Compliance Management New Zealand Conformity Requirements Category Regulatory Agency Regulations Energy Efficiency and Conservation Authority (ECCA) Energy Efficiency: New Zealand’s energy efficiency programs are closely linked to those of Australia. Minimum Energy Performance Standards (MEPS) are required for many products. Mandatory Star Rating Label Scheme is required for certain products. Environmental Guidelines Registration applications must be made in the format as prescribed in the applicable New Zealand Standard. Test procedures, comparative labelling and MEPS requirements are mostly contained in joint Australian and New Zealand standards. Applicable Product Categories A full list of product categories may be found at http://www.eeca.govt.nz/standards-and-ratings/minimum-energy-performance-standards-and-labelling To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with New Zealand requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 48 Quick Access to Global Markets 04 Country Regulations Brunei Darussalam General Specifications Voltage Frequency Manual Language 240V (Single Phase); 415V (Three Phase) 50Hz Malay/English Regulatory Agency Regulations Department of Electrical Services (DES, Prime Minister Office) For registration, products must conform to safety requirements according to standards stipulated by the DES under the Electricity Act. Compliance with IEC standards. Electrical Safety Global Market Access 02 International Compliance Management Brunei Darussalam Conformity Requirements Category 01 Guidelines Suppliers registering products should register through the Product Procurement Section. Approval of product will be endorsed by the Registration Committee upon satisfactory conformity assessment – quality assurance details, test reports and certification by International test bodies, etc. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Brunei requirements and obtaining the necessary approvals. As a listed CB for Brunei under the ASEAN EE MRA, TÜV SÜD’s test reports and CoC are accepted by the DES for registration. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 49 Quick Access to Global Markets 01 04 Country Regulations Brunei Darussalam Global Market Access 02 International Compliance Management Brunei Darussalam Conformity Requirements Category Regulatory Agency Regulations Authority for Infocommunications Technology Industry (AITI) A Dealer Telecommunication Equipment (DTQ) license is required for any mode of wired communication equipment. A Dealer Radio-communication Equipment (DRQ) license is required for any mode of wireless communication equipment. A Dealer Satellite Equipment (DSQ) license is required for any mode of satellite broadcasting equipment. Test report to EN standards is accepted and no samples are required. An import permit is required for products to enter customs, upon type approval of equipment. EMC: EMC compliance is required for the above, where applicable. Telecoms & Wireless Guidelines A local representative is required. Type Approval Procedure: 1. Registration for license 2. Application for type approval 3. Submission of test report and essential documents 4.Review 5. Issuance of Type Approval 6. Issuance of import permit Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Brunei requirements and obtaining the necessary approvals. TÜV SÜD can also perform the required testing to EN standards. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 50 Quick Access to Global Markets 01 04 Country Regulations Brunei Darussalam Global Market Access 02 International Compliance Management Brunei Darussalam Conformity Requirements Category Regulatory Agency Regulations Ministry of Health (MOH) Government is still working on developing laws or guidelines for medical devices. Medical Device Guidelines In the future, Brunei will be required to pass laws with the same provisions as the ASEAN Medical Device Directive (AMDD) – an overall regulation to harmonize medical device in ASEAN countries. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining international compliance with medical device requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 51 Quick Access to Global Markets 01 04 Country Regulations Brunei Darussalam Global Market Access 02 International Compliance Management Brunei Darussalam Conformity Requirements Category Environmental Regulatory Agency Regulations Energy Labelling and Standards Task Force of Energy Division, Prime Minister’s Office Energy Efficiency: There are currently no mandatory requirements in Brunei. Energy labelling scheme* is voluntary for room air conditioners. The Energy Label will be issued in the form of a certificate and shall be based on a 5-Star rating scheme. Guidelines Manufacturers who wish to participate in the Energy Labelling Scheme may submit applications for both supplier registration and product registration to the Division. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Brunei requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. * Wireless and EMC requirements are similar in Australia and New Zealand; the approvals applied in Australia also indicate similar compliance in New Zealand, vice versa. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 52 Quick Access to Global Markets 04 Country Regulations Cambodia General Specifications Voltage Frequency Manual Language 230V (Single Phase); 400V (Three Phase) 50Hz Khmer/French Electrical Safety Regulatory Agency Regulations Institute of Standards of Cambodia (ISC) & Ministry of Industry, Mines and Energy (MIME) The ISC Product Certification Scheme provides rules for third-party certification system of conformity assessment through testing and assessment of the factory quality management system. The scheme is mandatory for products covered under mandatory standards. Manufacturers are required to apply for a Product Registration License to affix the ISC Mark on products. Compliance with CS and/or IEC standards. Guidelines Foreign manufacturers need to sign an agreement for using the ISC Mark, and a local representative is required. Licensing Procedure: 1.Application 2. Preliminary inspection, sampling and testing 3. Assessment of quality assurance system and second sampling and testing Applicable Product Categories 4. Agreement signing Products categories under the mandatory scheme generally include any domestic electrical and electronic product; any product which is usually sold directly to the general public; or any product which does not require special skills in its operation. 5. Issuance of license A full list of product categories may be found at http://www.isc.gov.kh/LawNRegulation/ Prakas20100320EEE-Eng.pdf To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Cambodia requirements and obtaining the necessary approvals. Global Market Access 02 International Compliance Management Cambodia Conformity Requirements Category 01 6. Publication in ISC bulletin and/or website 7. Surveillance sampling and testing at six-month intervals 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview As a listed CB for Cambodia under the ASEAN EE MRA, TÜV SÜD’s test reports and CoC are accepted by ISC for safety approval. 53 Quick Access to Global Markets 01 04 Country Regulations Cambodia Global Market Access 02 International Compliance Management Cambodia Conformity Requirements Category Regulatory Agency Regulations Ministry of Posts and Telecommunications (MPTC) Manufacturers of regulated products need to obtain a license, and equipment requires Type Approval, issued by MPTC. Test reports to EN and FCC standards are accepted. EMC: EMC compliance is required for the above, where applicable. Telecoms & Wireless Guidelines A local representative is required. Type Approval Procedure: 1. Registration for license 2. Submission of application for type approval, test report and essential documents 3. Product sample review 4. Issuance of Type Approval Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Cambodia requirements and obtaining the necessary approvals. TÜV SÜD can also perform the required testing to EN standards. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 54 Quick Access to Global Markets 01 04 Country Regulations Cambodia Global Market Access 02 International Compliance Management Cambodia Conformity Requirements Category Regulatory Agency Regulations Ministry of Health Government is still working on developing laws or guidelines for medical devices. Medical Device Guidelines In the future, Cambodia will be required to pass laws with the same provisions as the ASEAN Medical Device Directive (AMDD) – an overall regulation to harmonize medical device in ASEAN countries. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining international compliance with medical device requirements and obtaining the necessary approvals 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 55 Quick Access to Global Markets 01 04 Country Regulations Cambodia Global Market Access 02 International Compliance Management Cambodia Conformity Requirements Category Regulatory Agency Regulations Ministry of Health There are currently no environmental requirements in Cambodia. Environmental TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in obtaining voluntary international endorsement labels. Guidelines 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 56 Quick Access to Global Markets 04 Country Regulations China General Specifications Voltage Frequency Manual Language 220V (Single Phase); 380V (Three Phase) 50Hz Simplified Chinese Electrical Safety Regulatory Agency Regulations Certification and Accreditation Administration of the People’s Republic of China (CNCA) & China Quality Certification Centre (CQC) Any product covered by the CCC catalogue of products should acquire the CCC Mark as a form of compulsory certification. Products must be tested in China by an accredited test lab. A CQC auditor must conduct the initial factory inspection. Manufacturers must submit their CCC application to an authorized CB. Compliance with GB standards. EMC: EMC compliance is required for the above, where applicable. Global Market Access 02 International Compliance Management China Conformity Requirements Category 01 Guidelines Certification Procedure: 1. Submit an application and supporting materials to an authorized CB 2. Test product samples in a CNCAdesignated test laboratory in China 3. Initial factory inspection by CQC representatives 4. Gain approval of the CCC Certificate 5. Obtain CCC Mark 6. Annual Follow-up Factory Inspections by Chinese officials 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 57 Quick Access to Global Markets 01 04 Country Regulations China Global Market Access 02 China Conformity Requirements Applicable Product Categories Products categories requiring CCC Mark include: • Electrical wires and cables • Switches for circuits, installation protective and connection devices • Low-voltage electrical apparatus • Small power motors • Electric tools • Welding machines • Household and similar use appliances • Audio and video apparatus • Information Technology Equipment • Lighting apparatus • Telecommunication terminal equipment • Motor vehicles and safety parts and tires • Safety glasses • Agricultural machinery • Latex products • Medical devices • Fire-fighting products • Detectors for intruder alarm systems • Decoration material • Toy products To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD provides full CCC services including document preparation and pre-check, application for certification, coordination for type test and initial factory inspection, release of certification and test report, obtaining CCC Mark and coordination for follow-up factory inspection. International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 58 Quick Access to Global Markets 01 04 Country Regulations China Global Market Access 02 International Compliance Management China Conformity Requirements Category Telecoms Regulatory Agency Regulations Ministry of Industry & Network Access License (NAL) Approval is mandatory Information Industry (MIIT) for all telecommunications equipment covered by the NAL product categories announced by MIIT. Testing must be conducted in MIIT designated laboratories in China. MIIT’s NAL Certification Centre is the only authorized certification organization. Each type of approved product will be issued a Network Access Identifier (NAI) with the certification number. Guidelines NAL* Approval Procedure: 1. Submit an application 2. Get product tested by MIIT accredited test labs 3. Go through a quality audit 4. Obtain an approval certificate 5. Label products appropriately Applicable Product Categories 28 types of telecom products that are divided into the two main groups – regular equipment and high-end equipment. Regular equipment includes telecommunication terminal equipment while high-end equipment includes radio telecommunication equipment and internet equipment. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with China requirements and obtaining the necessary approvals. * Since some telecommunication products are subject to both NAL Approval and CCC Certification, applicants are advised to apply for the NAL Approval first before CCC Certification, to avoid repeat testing, because some parts of the NAL test results may be used for CCC Certification. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 59 Quick Access to Global Markets 01 04 Country Regulations China Global Market Access 02 International Compliance Management China Conformity Requirements Category Regulatory Agency Regulations State Radio Regulation Centre (SRRC) Radio Type Approval from SRRC is compulsory to all products with radio modular. SRRC is the only designated certification organization for Radio Type Approval, and the State Radio Monitoring Centre (SRMC) is the only designated testing organization. No formal mark is required apart from a certificate number that must appear on products or labels. Wireless Guidelines Radio Type* Approval Procedure: 1. Submit an application 2. Test the product locally at SRMC 3. Have the test report reviewed 4. Obtain an approval certificate from SRRC Applicable Product Categories 28 types of telecom products that are divided into the two main groups – regular equipment and high-end equipment. Regular equipment includes telecommunication terminal equipment while high-end equipment includes radio telecommunication equipment and internet equipment. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with China requirements and obtaining the necessary approvals. * It should be noted that some radio emission products not only fall into the production scope of Radio Type Approval but also that of CCC Certification and/ or Network Access License (NAL) Approval. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 60 Quick Access to Global Markets 01 04 Country Regulations China Global Market Access 02 International Compliance Management China Conformity Requirements Category Regulatory Agency Regulations State Food and Drug Administration (SFDA) The Regulations for Supervision and Administration of Medical Devices regulates medical devices. Medical devices are classified as Class I, II, III. All imported medical device are required to register with SFDA. Certain devices are also regulated by CQC under CCC Mark (See Electrical Safety). Medical Device Guidelines Registration Procedure: 1. Compile product Standard. 2. Coordinate with SFDA test centre and get the test report. 3. Application to SFDA. 4. SFDA Technical File review. 5. Obtain SFDA registration. Applicable Product Categories The 8 product categories that are further regulated by CQC include: • Medical diagnostic x-ray equipment • Haemodialysis equipment • Hollow fiber dialysers • Extra-corporeal blood circuit for blood purification equipment • Electrocardiographs • Implantable cardiac pacemakers • Artificial heart-lung machine • Rubber condoms To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with China requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 61 Quick Access to Global Markets 01 04 Country Regulations China Global Market Access 02 International Compliance Management China Conformity Requirements Category Environmental Regulatory Agency Regulations China National Institute of Standardization (CNIS) Energy Efficiency: Minimum Energy Performance Standards (MEPS) are required for many products. Mandatory labelling required for certain products. Manufacturers need to register compliance online with the China Energy Label Website. Testing must be performed by recognized accredited test labs. Ministry of Industry & RoHS: Information Industry (MIIT) Applies to all Electronic Information Products (EIP) on 2 levels. All EIPs must be marked with Symbol 1 or 2 to indicate presence of any of the six substances. Substance restrictions will be specified for products listed in the catalogue. Guidelines Manufacturers need to submit essential documentation and test reports to obtain approval. Registered products will be listed on the website. Self declaration is required for the marking of all EIPs. Testing must be performed by authorised labs in China of the catalogue listed products. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 62 Quick Access to Global Markets 01 04 Country Regulations China Global Market Access 02 International Compliance Management China Conformity Requirements Applicable Product Categories Product categories that require energy efficiency labelling include: • Air conditioners • Refrigerators • Domestic cookers • Chillers • Small motors • Fans • Lamps • Water heaters • Copiers • Washing machines • Power transformers • Computer monitors • Air compressors A full list of product categories may be found at http://test.energylabel.gov.cn/Download.aspx?navl=guide&CID=49 To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with China requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 63 Quick Access to Global Markets 04 Country Regulations Hong Kong General Specifications Voltage Frequency Manual Language 220V (Single Phase); 380V (Three Phase) 50Hz English/Simplified Chinese Electrical Safety Regulatory Agency Regulations Electrical & Mechanical Services Department (EMSD), Government of the Hong Kong Special Administrative Region All electrical products within the scope of control of the Electrical Products (Safety) Regulation (EPSR) are required to comply with the applicable requirements. Prescribed products require certification under an approval regime requiring type testing. Non-prescribed products require supplier declarations while certification is also an option. Compliance with IEC standards. Global Market Access 02 International Compliance Management Hong Kong Conformity Requirements Category 01 Guidelines A local representative is required. Certification Procedure: Testing to applicable standards should be performed by a recognized CB or recognized manufacturers. Certificates are issued by a recognized CB, or DoC is issued by recognized manufacturers*. Supplier Declaration Procedure: Manufacturers take responsibility and hold relevant compliance documents for subsequent audits. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group Office of the Telecommunications Authority (OFTA) EMC compliance is required for the above, where applicable. Manufacturers are required to keep test reports for possible request of files. EMC * 06 Quick Reference Overview Recognized manufacturers are those manufacturers who are recognized by EMSD as qualified to issue certificates of safety compliance for the products manufactured by them. 64 Quick Access to Global Markets 01 04 Country Regulations Hong Kong Global Market Access 02 Hong Kong Conformity Requirements Applicable Product Categories Prescribed Products include: • Plugs • Adaptors • Lampholders • Flexible cords • Extension units • Unvented thermal storage type electric water heaters Non-prescribed products include all other electrical products. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Hong Kong requirements and obtaining the necessary approvals. TÜV SÜD is a recognized CB able to perform testing and issue certificates to manufacturers. International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 65 Quick Access to Global Markets 01 04 Country Regulations Hong Kong Global Market Access 02 International Compliance Management Hong Kong Conformity Requirements Category Regulatory Agency Regulations Office of the Telecommunications Authority (OFTA) The Hong Kong Telecommunications Equipment Evaluation and Certification (HKTEC) Scheme divides certification requirement into Voluntary Certification Scheme* (VCS) and Compulsory Certification Scheme (CCS). Testing must be performed by Recognized Testing Agencies (RTA) and certification issued by a recognized CB. EMC: EMC compliance is required for the above, where applicable. Telecoms & Wireless Guidelines Equipment classified under VCS need not be certified while those classified under CCS require CB certification. Under the HKTEC Scheme, manufacturers may affix, on a voluntary basis, a label prescribed by OFTA to VCS or CCS certified equipment. Applicable Product Categories VCS and CCS classification of telecoms equipment may be found at http://www.ofta.gov.hk/en/tec/information-notes/in412.pdf and http://www.ofta.gov. hk/en/tec/information-notes/in416.pdf VCS and CCS classification of wireless equipment type may be found at http://www.ofta.gov.hk/en/tec/information-notes/in401.pdf To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Hong Kong requirements and obtaining the necessary approvals. TÜV SÜD is also able to perform testing to EN standards which can be used for wireless certification. * Although certification of equipment under this VCS is voluntary, equipment must comply with the relevant specifications. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 66 Quick Access to Global Markets 01 04 Country Regulations Hong Kong Global Market Access 02 International Compliance Management Hong Kong Conformity Requirements Category Medical Device Regulatory Agency Regulations Medical Device Control Regulatory framework is largely in line with that Office (MDCO), Department recommended by the Global Harmonization Task Force of Health (DOH) (GHTF). Under the MDACS*, manufacturers of class II, III and IV devices can voluntarily list products with the DOH after obtaining a conformity assessment certificate or marketing approval from other countries which have adopted the GHTF model. Conformity assessment can be conducted by MDCOrecognized CAB. Manufacturers and importers must also be listed online. Guidelines A Local Responsible Person (LRP) is required. Conformity includes a quality management system, a post-market surveillance system, technical documentation and a DoC. The list of devices will be posted on the MDCO website. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Hong Kong requirements and obtaining the necessary approvals. TÜV SÜD has been recognized by DOH as a CAB under the MDACS. * There is currently no specific legislative control over the importation and sale of medical devices in Hong Kong. An administrative control system called Medical Device Administrative Control System (MDACS) has been set up to facilitate the transition to the long-term statutory control. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 67 Quick Access to Global Markets 01 04 Country Regulations Hong Kong Global Market Access 02 International Compliance Management Hong Kong Conformity Requirements Category Regulatory Agency Regulations Electrical & Mechanical Services Department (EMSD) Energy Efficiency: Under the Energy Efficiency (labelling of products) Ordinance, a prescribed product is required to bear an energy label that complies with the specified requirement. The mandatory Energy Efficiency Labelling Scheme (EELS) is applied in 2 phases* – the second phase will have an extended coverage. Manufacturers of other products are also encouraged to participate in the voluntary EELS. Environmental Guidelines Manufacturers are required to submit product information and test report to EMSD. If accepted, a reference number will be assigned to the product model which will then be included in the EMSD record. Applicable Product Categories Product categories under the mandatory EELS include: • Air conditioners (1st phase) • Refrigerating appliances (1st phase) • Compact fluorescent lamps (1st phase) • Washing machines (2nd phase) • Dehumidifiers (2nd phase) To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Hong Kong requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. * 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview The initial phase of the MEELS has been fully implemented since November 2009. The second phase commenced on 19 March 2010 and has an 18-month grace period. 68 Quick Access to Global Markets 04 Country Regulations India General Specifications Voltage Frequency Manual Language 230V (Single Phase); 400V (Three Phase) 50Hz Hindi/English Electrical Safety Regulatory Agency Regulations Bureau of Indian Standards ISI Mark, or Standard Mark, is issued by BIS under its (BIS), Ministry of Consumer certification scheme. Affairs, Food & Product Distribution ISI certification* is a self-regulation scheme. The scheme itself is voluntary; however, the Government has enforced mandatory certification on various products. While BIS grants licences on application, the enforcement of compulsory certification is done by the notified authorities – in this case, officers appointed by State Government/Central Government. Compliance with ISO Guide 28 and 65. Guidelines A local representative is required. ISI Certification Normal Procedure: 1. Submit application with essential documents to BIS 2. Factory inspection by BIS officer 3. Testing in factory and drawn for independent testing 4. License granted The Simplified Procedure** Requires submission of application with test reports issued by BIS approved test labs. * ** Certification procedure and submission requirements differ between foreign manufacturers and Indian importers. Simplified procedure is not granted to some items under mandatory certification and all first-time licenses for any product. Global Market Access 02 International Compliance Management India Conformity Requirements Category 01 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 69 Quick Access to Global Markets 01 04 Country Regulations India Global Market Access 02 International Compliance Management India Conformity Requirements Applicable Product Categories Product categories requiring ISI certification include: • • • Electric Irons Electric stoves Switches • • • Electric Radiators Electric Lamps Circuit breakers • Electric immersion water heaters • Cables • Etc. A full list of product categories may be found at http://www.bis.org.in/cert/man.htm To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with India requirements and obtaining the necessary approvals. TÜV SÜD is a RCB for India and is able to perform testing and issue mandatory ISI certification for Residual Current Circuit Breakers. TÜV SÜD is also able to support manufacturers in attaining the voluntary S Mark under the Safety Certification Scheme operated by STQC. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 70 Quick Access to Global Markets 01 04 Country Regulations India Global Market Access 02 International Compliance Management India Conformity Requirements Category Telecoms Wireless Regulatory Agency Regulations Telecommunication Engineering Centre (TEC), Department of Telecommunications Type approval is required to indicate compliance with Generic Requirements (GR). Interface approval is required to indicate compliance with Interface Requirements (IR) Certification of approval is issued against applicants’ own specifications when IR/GR is not available, and in particular cases*. EMC: EMC compliance is required for the above, where applicable. Wireless Planning and Coordination (WPC) Wing, Ministry of Communications and IT Guidelines A local representative is required. Manufacturers need to submit application with essential documents and test reports to the respective agencies. Testing must be performed by in-country test labs. Type approval is required for import of wireless equipment for use in the existing allocated frequency bands. New Frequency Allocation is required for use of wireless equipment in a new frequency band that needs to be allocated. Online-filing of all types of license applications is mandatory, followed by submission of hard copy of the license application. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with India requirements and obtaining the necessary approvals. * TEC issues certification of approval in particular cases viz. GSM Phones, 3G Modems, Bluetooth Enabled wireless terminals against approved Standards of Standard Body. 71 Quick Access to Global Markets 01 04 Country Regulations India Global Market Access 02 International Compliance Management India Conformity Requirements Category Regulatory Agency Medical Device Central License Approving Authority (CLAA) & Central Drugs Standard Control Regulations Currently, certain medical devices are regulated under the Drugs & Cosmetics Act 1940, i.e. their treatment is similar to that of drugs/medicines. Such devices require approval from CDSCO. For imported devices, registration and import license are required. Organization (CDSCO), For locally manufactured devices, a grant of license is Directorate General of Health Services, Ministry of required after evaluation. Health and Family Welfare, For the sale of devices, appropriate sale licenses are Government of India required. CDSCO* has uploaded the proposed requirements for future regulatory control of medical devices. Applicable Product Categories A full list of product categories under current regulations may be found at http://www.cdsco.nic.in/List%20 of%20Notified%20Medical%20devices.pdf Guidelines A local representative is required. Import registration requires: 1. Submission of applicant details and product information 2. Evidence of approval from other country(s) regulatory agency and related certification if any 3. Master file (details of Good Manufacturing Practices employed) 4. Post-market surveillance 5. Undertaking of conformity with respect to requirements in country of origin To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with India requirements and obtaining the necessary approvals. * Under Schedule M-III, the proposed regulation follows the same structure as the EU Medical Device Directive 93/42/EEC. Device classifications A, B, C and D are harmonized with the Global Harmonization Task Force. The proposed requirements are summarized as follows: • Class A and Class B device manufacturers need not obtain a manufacturing license but are required to register with the CLAA. For Class B devices, it is also required that a Notified Body assesses and certifies the manufacturing facility for quality systems. • Class C and Class D devices require certification by a Notified Body with regard to design and manufacturing. Manufacturers are then required to apply for a manufacturing license and submit essential documents to CLAA. For Class D devices, it is also required that the manufacturing facility be jointly inspected by CLAA and the state licensing authority. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 72 Quick Access to Global Markets 01 04 Country Regulations India Global Market Access 02 International Compliance Management India Conformity Requirements Category Regulatory Agency Environmental Regulations Bureau of Energy Efficiency Energy Efficiency: (BEE), Ministry of Power Mandatory energy efficiency Star Label is required for certain products under the Standards & Labelling Program. Requirements for each product are specified in its schedule. RoHS & WEEE: The Indian government has published proposals* for legislation on the disposal of WEEE; this includes RoHS. Guidelines Manufacturers are required to register themselves for the Standards & Labelling Program and file an e-application for the Star Label. Labelled equipment are listed on the BEE website. Product categories under the mandatory scheme include: Frost-free refrigerators • Distribution Transformers • Tubular florescent lamps • Room air conditioners A full list of product categories may be found at http://220.156.189.23:8080/beeLabel/index.jsp To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with India requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. * Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA Applicable Product Categories • 03 05 TÜV SÜD Group 06 Quick Reference Overview The scope proposed is similar to EU WEEE and includes medical devices and monitoring and control instruments. However, requirements need further clarification and would only enter into force 3 years after the adoption of the legislation. 73 Quick Access to Global Markets 04 Country Regulations Indonesia General Specifications Voltage Frequency Manual Language 230V (Single Phase); 400V (Three Phase) 50Hz Bahasa Indonesia/English Electrical Safety Regulatory Agency Regulations Ministry of Energy and Mineral Resources & Ministry of Industry Both Ministries regulate a list of electrical and electronic equipment each. The SNI Mark is a mandatory safety mark for regulated products. Product testing by accredited in-country test lab and factory quality system control is required. Certificates should be issued by an accredited CB. Compliance with Indonesia National Standards (SNI). Global Market Access 02 International Compliance Management Indonesia Conformity Requirements Category 01 Guidelines Certification Procedure: 1. Submission of application and essential documents 2. Product testing by random sample 3. Factory inspection 4. Certification 5. Appropriate usage of SNI Mark Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indonesia requirements and obtaining the necessary approvals. As a listed CB for Indonesia under the ASEAN EE MRA, TÜV SÜD’s test reports and CoC are accepted for SNI certification. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 74 Quick Access to Global Markets 01 04 Country Regulations Indonesia Global Market Access 02 International Compliance Management Indonesia Conformity Requirements Category Telecoms & Wireless Regulatory Agency Regulations Directorate General of Posts and Telecommunications (DGPT) Certification by type approval of regulated products is required. Product testing should be performed by in-country test lab. Certification is issued by DGPT. Guidelines Application must be made by the local importer. Certification process: 1.Application 2. Product testing 3. Submission of test report and essential documents 4. Approval of certification 5. Product labelling as appropriate Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indonesia requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 75 Quick Access to Global Markets 01 04 Country Regulations Indonesia Global Market Access 02 International Compliance Management Indonesia Conformity Requirements Category Medical Device Regulatory Agency Regulations Directorate for Drug and Medical Devices Control, Ministry of Health Republic of Indonesia Registration of medical devices is required for both domestically manufactured and imported devices. Applications should be submitted to the Indonesian Director General of Food and Drugs. Registration application for imported devices should be accompanied with evidence that they have been officially traded overseas. Guidelines A local representative is required for registration of imported products. A registration number will be allocated once the application is approved. In the future, Indonesia will be required to pass laws with the same provisions as the ASEAN Medical Device Directive (AMDD) – an overall regulation to harmonize medical device in ASEAN countries. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indonesia requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 76 Quick Access to Global Markets 01 04 Country Regulations Indonesia Global Market Access 02 International Compliance Management Indonesia Conformity Requirements Category Regulatory Agency Regulations Directorate General of Electricity and Energy Utilization Energy Efficiency: The Indonesian government is developing residential appliance efficiency standards and labelling programs. Voluntary labels have been established for refrigerators and are currently under consideration for other products. Environmental Guidelines Although there are currently no standards for any products, voluntary environmental standards are being considered for several products. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Indonesia requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 77 Quick Access to Global Markets 04 Country Regulations Japan General Specifications Voltage Frequency Manual Language 100V (Single Phase); 200V (Three Phase) 50/60Hz Japanese Electrical Safety Regulatory Agency Regulations Ministry of Economy, Trade The PSE Mark is a mandatory safety mark under & Industry (METI) DENAN Law. Testing by an accredited test lab is required. Category A: Specified Electrical Appliances and Materials must be marked with Diamond PSE Mark. Products require factory inspection and certification by a RCAB. Category B: Non-Specified Electrical Appliances and Materials must be marked with Circle PSE Mark. Products do not require CAB certification. Compliance with JIS standards. EMC: EMC compliance is required for the above, where applicable. Applicable Product Categories PSE Mark Category A consists of 115 items such as cables and cords, thermal fuses, battery charges, DC power supply units, etc. Global Market Access 02 International Compliance Management Japan Conformity Requirements Category 01 Guidelines A local importer or “Notifying Supplier” is required. Notifying Suppliers are responsible for: • Submitting the Business Commencement Report • Confirming that the products comply with DENAN or IEC standards • Affixing the PSE Mark as applicable • Submitting product inspection records to METI upon request, etc Manufacturers are responsible for: PSE Mark Category B consists of 338 items such as electric irons, vacuum cleaners, washing machines, microwave ovens, television receivers, etc. • Conducting product inspection To determine if a particular product is subject to the above regulations, please Contact Us. • Maintaining test equipment TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Japan requirements and obtaining the necessary approvals. • Maintaining the product inspection records for 3 years, etc 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview TÜV SÜD is a RCAB with the capability to issue the CoC for all 338 items of Cat B products and 7 groups of the Cat A Specified Products. 78 Quick Access to Global Markets 01 04 Country Regulations Japan Global Market Access 02 International Compliance Management Japan Conformity Requirements Category Regulatory Agency Regulations Ministry of Internal Affairs Manufacturers must seek an Independent MIC RCAB and Communications (MIC) to certify conformity and obtain MIC Mark. Terminal equipment is divided into 2 categories – Terminal equipment for the purpose of calls and other Telecoms & Wireless terminal equipment. Radio equipment is divided into 3 categories according to legal effects – Unlicensed station, Licensed station (Blanket license) and Licensed station (subject to simplified licensing procedure or registration). VCCI Council EMC IT Equipment should comply with EMC requirements under Regulations for Voluntary Control Measures*. Equipment intended for the domestic environment must comply with the Class B requirements, while other equipment should satisfy the Class A requirements. Test reports need to be obtained from test labs that are registered with VCCI. Testing for compliance with CISPR 22. Guidelines As a general guide, Telecoms & Wireless Approval Procedure: 1.Application 2. Product testing 3. Pre-license procedures 4.Inspection 5. Issuance of license The approval process also depends on the category in which the product falls. EMC Approval Procedure: 1. Register and become a member of VCCI Applicable Product Categories 2. Obtain test report To determine if a particular product is subject to the above regulations, please Contact Us. 3. Submit Conformity Verification Report TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Japan requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 4. Upon approval, label products accordingly As a MIC RCB, TÜV SÜD is able to perform testing and issue/obtain certification for manufacturers. * Although not mandatory, it is widely supported by the Japanese industry and increasingly perceived as an indication of product quality; it is highly recommended for marketing reasons. 79 Quick Access to Global Markets 01 04 Country Regulations Japan Global Market Access 02 International Compliance Management Japan Conformity Requirements Category Regulatory Agency Regulations Ministry of Health, Labour and Welfare (MHLW) Japanese Pharmaceutical Affairs Law (PAL) regulates Medical Devices, IVD reagents, medicines, toiletry products and cosmetics. For medical devices and IVD reagents, the following are regulated: Class I products do not require involvement of an independent party. Class 2 products require certification through a “RCB “. Class 3 and 4 products need to be approved by the MHLW after evaluation by Pharmaceuticals and Medical Devices Agency (PMDA) Medical Device Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Japan requirements and obtaining the necessary approvals. Within the realm of its status of RCB according to PAL, TÜV SÜD can conduct the certification for all applicable products. Guidelines A local marketing business unit is necessary. An official application has to be submitted describing the medical device in detail. In the case of a certification, the CB needs to prove that the respective product requirements as stated in the “Certification Criteria” (regulated by MHLW Notices) have been met via documentation, such as the Summary Technical Documentation (STED). The “Good Manufacturing Practice” of the respective manufacturing facilities can be proven through documentation or within the framework of an audit. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 80 Quick Access to Global Markets 01 04 Country Regulations Japan Global Market Access 02 International Compliance Management Japan Conformity Requirements Category Environmental Regulatory Agency Regulations Ministry of Economy, Trade and Industry (METI) & Ministry of Land, Infrastructure and Transport Energy Efficiency: Products need to comply with the standards of Energy Conservation Law, also the basis for the Top Runner Program and the Energy-saving Labelling Program*. Business operators, constructors of non-residential buildings and transportation carriers also need to plan and report the status of their energy utilization. Ministry of Economy, Trade and Industry (METI) & Ministry of Land, Infrastructure and Transport * WEEE & RoHS: Compliance with J-MOSS which requires marking the presence of the specific chemical substances for electrical and electronic appliances (similar to EU RoHS). Compliance with the Law for Recycling of Specified Kinds of Home Appliances; manufacturers are required to collect and finance recycling of their own appliances. Although a voluntary program, Energy-saving Labels are actively utilized in Japan and recommended for marketing reasons. Guidelines Under the Top Runner Program, manufacturers are required to surpass a weighted average value for all their products per category for each predetermined target year. Companies that sell a limited number of products in the market can designate other organizations to fulfil collection and recycling responsibilities on their behalf. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 81 Quick Access to Global Markets 01 04 Country Regulations Japan Global Market Access 02 International Compliance Management Japan Conformity Requirements Applicable Product Categories Applicable products under the Top Runner Program include: • Passenger vehicles • Freight vehicles • Air conditioners • TV sets • Video-cassette recorders • Fluorescent lights • Copiers • Computers • Magnetic discs units • Electric refrigerators • Electric freezers • Space heaters • Gas cooking appliances • Gas water heaters • Oil water heaters • Electric toilet seats • Vending machines • Transformers • Electric rice cookers • Microwaves • DVD recorders Applicable product categories under Energy-saving Labelling Program include: • Air conditioners • Refrigerators • Freezers • Fluorescent lights • TV sets • Space heaters • Gas cooking appliances • Gas water heaters • Oil water heaters • Electric toilet seats • Computers • Magnetic disks • Transformers • DVD recorders • Rice cookers • Micro wave ovens To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Japan requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 82 Quick Access to Global Markets 04 Country Regulations Korea (South) General Specifications Voltage Frequency Manual Language 110V / 220V (Single Phase); 380V (Three Phase) 60Hz Korean/English Electrical Safety * Global Market Access 02 International Compliance Management Korea (South) Conformity Requirements Category 01 Regulatory Agency Regulations Ministry of Knowledge Economy (MKE) All products subject to legally compulsory certification are required to affix the new national unified KC Mark. (As of 1 Jan 2009)* Certification Procedure for Type 1: Products are categorized into 2 groups: Type 1 products require certification by a designated CB. Type 2 products fall under a self-regulatory safety confirmation scheme. Compliance with K standards. EMC: EMC compliance is required for the above, where applicable. 2. Factory inspection Guidelines 1. Submission of application along with other essential documents 3. Product testing 4. Issuance of certificate by the designated CB Compliance procedure for Type 2 is the same except that factory inspection is exempted and Confirmation Letter of Declaration is needed in place of certification. Products that have been certified in accordance with relevant regulations before 1 Jan 2009 can continue to bear the existing marks; they can be used alongside the KC Mark until 30 June 2011. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 83 Quick Access to Global Markets 01 04 Country Regulations Korea (South) Global Market Access 02 Korea (South) Conformity Requirements Applicable Product Categories Only electrical apparatus using AC 50V up to 1000V are subject to KC mark certification. Product categories (may consist both Type 1 & 2) requiring KC Mark include: • Cables and cords • Switches for electrical appliances • Capacitors or filters as components for power supply unit • Installation accessories and connection devices • Installation protective equipment • Safety transformer and similar equipment • Household and similar electrical appliances • Motor tools • IT and office appliances • Audio, video and similar electronic appliances • Lighting To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Korea requirements and obtaining the necessary approvals. TÜV SÜD is an MOU partner of the Korea Testing Laboratory (KTL). Test reports issued by TÜV SÜD are thus acceptable to KTL for issuance of the KC Mark. International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 84 Quick Access to Global Markets 01 04 Country Regulations Korea (South) Global Market Access 02 International Compliance Management Korea (South) Conformity Requirements Category Regulatory Agency Regulations Korean Communications Commission (KCC)* Applicable products are required to be certified and affixed with the KCC Mark**. Terminal equipment need to obtain type approval. Radio facilities and equipment need to obtain either type verification or type registration depending on the product. Type verification test should only be conducted by the Radio Research Agency (RRA) only. EMC: IT equipment need to obtain EMC registration. Telecoms & Wireless Guidelines A local representative is required. KCC Mark Procedure: 1. Apply for testing at designated test lab 2. Apply for certification 3. Submit essential documents 4. Certification 5. Affix KCC Mark Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Korea requirements and obtaining the necessary approvals. * ** KCC was formed in 2008 after consolidating the former Ministry of Information and Communication (MIC) and the Korean Broadcasting Commission (KBC). KCC Mark is the present mandatory certification mark. However, in the future, it will also be unified under the KC Mark, changing the mandatory nature of obtaining certification for all applicable products. The date of its implementation is still tentative. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 85 Quick Access to Global Markets 01 04 Country Regulations Korea (South) Global Market Access 02 International Compliance Management Korea (South) Conformity Requirements Category Regulatory Agency Regulations Korea Food & Drug Administration (KFDA) Medical devices must be approved for sale in their country-of-manufacture before they can be eligible for registration in Korea. All local medical devices manufacturers must meet Korean Good Manufacturing Practice (KGMP). For foreign manufacturers, a Quality Management System (QMS) certificate recognized by the device’s country of origin must be submitted. All distributors must meet Korean Good Importing Practice (KGIP). Pre-market notification for class I devices and premarket approval for Class II, III and IV devices is required. Medical Device Guidelines A local representative is required. After classifying the product and obtaining the certificate of Free Sale – Pre-market notification involves: • Submission of Form 5 • QMS certificate (KGMP or equivalent recognized by country of origin) • KGIP certificate (for importers) Pre-market approval involves: Applicable Product Categories • Submission of Form 3 To determine if a particular product is subject to the above regulations, please Contact Us. • Technical File review (Form 7) TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Korea requirements and obtaining the necessary approvals. • QMS certificate (KGMP or equivalent recognized by country of origin) • KGIP certificate (for importers) 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 86 Quick Access to Global Markets 01 04 Country Regulations Korea (South) Global Market Access 02 International Compliance Management Korea (South) Conformity Requirements Category Environmental Regulatory Agency Regulations Ministry of Commerce, Industry and Energy (MOCIE) & Korea Energy Management Corporation (KEMCO) Energy Efficiency: Minimum Energy Performance Standards (MEPS) are required for many products. Compliance with Energy Efficiency Standards and Labelling Program & e-Standby Program for applicable products. Ministry of the Environment RoHS & WEEE: (MOE) Compliance based on the Act on the Recycling of Electrical and Electronic Equipment and Automobiles. Notification is required. Guidelines Testing for energy efficiency labelling must be performed by designated test labs, mostly in-country. Reporting should be made to KEMCO. 03 Application of the Guidebook 04 There is a regulated recycling ratio and listed banned hazardous substances. Similar to European WEEE, RoHS and ELV. Applicable Product Categories There are 22 target products under the Energy Efficiency Standards and Labelling Program and 20 target products under the e-Standby Program. The lists of target products may be found at http://www.kemco.or.kr/new_eng/pg02/pg02100101.asp To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Korea requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 87 Quick Access to Global Markets 04 Country Regulations Malaysia General Specifications Voltage Frequency Manual Language 240V (Single Phase); 415V (Three Phase) 50Hz Malay/English Electrical Safety Regulatory Agency Regulations The Energy Commission, Suruhanjaya Tenaga (ST) The Electrical Supply Act 1990 and Electrical Regulation 1994 require manufacturers to apply for Certificate of Approval (COA) and affix with the SIRIM Label or certification mark. Product testing is required. SIRIM QAS International is the testing and CB. Guidelines Application must be made by the local importer. Manufacturers should obtain COA from ST before applying for SIRIM Label or certification mark. Manufacturers can choose a batch inspection when products reach Malaysian customs or a factory inspection. Compliance with MS and/or IEC standards. Applicable Product Categories Product categories requiring SIRIM Label include: • • • Plug top/Plug Circuit breakers Domestic power tools • • • Switch and dimmer Household appliances Wires/Cables/Cords Global Market Access 02 International Compliance Management Malaysia Conformity Requirements Category 01 • Socket outlet • Lighting • Etc. A full list of product categories may be found at http://www.st.gov.my/index.php?option=com_content&task=view&id=5011&Itemid=1238 To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Malaysia requirements and obtaining the necessary approvals. As a listed testing laboratory for Malaysia under the ASEAN EE MOU. TÜV SÜD’s test reports are accepted by ST for safety approval. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 88 Quick Access to Global Markets 01 04 Country Regulations Malaysia Global Market Access 02 International Compliance Management Malaysia Conformity Requirements Category Telecoms & Wireless Regulatory Agency Regulations Malaysian Communications and Multimedia Commission (MCMC) Type Approval is required for fixed line and wireless telecommunications products. SIRIM QAS International is the designated CB. For telecoms equipment, testing must be performed by SIRIM. For wireless equipment, test reports to EN standards from accredited test labs are accepted EMC: EMC compliance is required for the above, where applicable. Guidelines Application must be made by the local importer. Upon approval, products should be labelled with SIRIM Label accordingly. Applicable Product Categories Regulated Telecoms Equipment include: • • • • Terminal equipment for Connecting to Public Switch Telephone Network (PSTN) Connecting to the Integrated Services Digital Network (ISDN) using basic access Connecting to the ISDN using primary rate access Analogue Calling Line Identity Presentation (ACLIP) facility for connection to PSTN • • • • • Private Automatic Branch Exchange (PABX) system for connection to PSTN Cordless telephone systems Asymmetric Digital Subscriber Line (ADSL) transceivers Overvoltage protective devices Low frequency cables and wires with PVC insulation and PVC sheath 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 89 Quick Access to Global Markets 01 04 Country Regulations Malaysia Global Market Access 02 Malaysia Conformity Requirements Applicable Product Categories Regulated Wireless Equipment include: • • • Short Range Devices (SRD) Broadband Wireless Access (BWA) Equipment GSM Mobile Terminals • IMT-2000 Third-Generation (3G) cellular mobile terminals • Amateur Radio Equipment • Land Mobile Radio Equipment To determine if a particular product is subject to the above regulations, please Contact Us TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Malaysia requirements and obtaining the necessary approvals. International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 90 Quick Access to Global Markets 01 04 Country Regulations Malaysia Global Market Access 02 International Compliance Management Malaysia Conformity Requirements Category Regulatory Agency Regulations Medical Devices Bureau (MDB), Ministry of Health Presently there is no statutory requirement to register medical devices in Malaysia. A Local Authorized Representative (LAR) is required. The definition of medical device is in accordance with the global harmonized (GHTF). All devices require QMS and PMS. The Conformity Assessment System includes Quality Management System (QMS), Technical documentation (CSDT), DoC and Post-Market Surveillance (PMS) system. Preparation of CSDT and DoC is required for all devices while submission of the said items is required for Class C and D devices. Medical Device Review of conformity assessment is performed by MDB or a CAB. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Malaysia requirements and obtaining the necessary approvals. Guidelines Devices should conform to Essential Principles for Safety and Performance (EPSP). 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA Manufacturers should register themselves and the medical devices with the MDB. 05 In the future, Malaysia will be required to pass laws with the same provisions as the ASEAN Medical Device Directive (AMDD) – an overall regulation to harmonize medical device in ASEAN countries. 06 TÜV SÜD Group Quick Reference Overview 91 Quick Access to Global Markets 01 04 Country Regulations Malaysia Global Market Access 02 International Compliance Management Malaysia Conformity Requirements Category Environmental Regulatory Agency Regulations The Energy Commission, Suruhanjaya Tenaga (ST) Energy Efficiency: Fiscal incentives have been introduced by the government for efficient electrical equipment and insulation material. Minimum Energy Performance Standards (MEPS) are required for certain products. Guidelines Application should be made to ST. Performance testing, where applicable, should be done by SIRIM QAS International or any lab recognized by Standard Malaysia. Energy Labelling Program is applicable and voluntary to certain products. Applicable Product Categories A full list of product categories may be found at http://www.st.gov.my/index.php?option=com_content&task=view&id=4331&Itemid=1238 To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Malaysia requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 92 Quick Access to Global Markets 04 Country Regulations Philippines General Specifications Voltage Frequency Manual Language 220V (Single Phase); 380V (Three Phase) 60Hz Filipino/English Electrical Safety Regulatory Agency Regulations Bureau of Product Standards (BPS), Department of Trade and Industry (DTI) Manufacturers need to comply with mandatory requirements by obtaining the Philippine Standard (PS) Quality Certification Mark License or (for imported products) the Import Commodity Clearance (ICC) Certification Mark, from BPS. Guidelines A local representative is required. PS Certification Procedure: 1. Application 2. Factory and product audit 3. Third-party independent testing 4. Test report evaluation Importers with PS certification only need a Certificate of exemption for ICC Mark. Factory inspection and product testing to applicable standards are required. Compliance with Philippine National Standards (PNS). Applicable Product Categories A full list of product categories may be found at http://www.bps.dti.gov.ph/component/option,com_ dbquery/Itemid,265/task,ExecuteQuery/qid,50/previousTask,PrepareQuery/ To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions Global Market Access 02 International Compliance Management Philippines Conformity Requirements Category 01 5. License to use PS mark 6. Surveillance ICC Certification Procedure 1. Application 2. Inspection and testing by BPS accredited test lab (not required if applicant has foreign test report) 3. Evaluation 4. Issuance of ICC 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Philippines requirements and obtaining the necessary approvals. As a listed testing laboratory for Philippines under the ASEAN EE MRA, TÜV SÜD’s test reports are accepted by BPS for application of the ICC. 93 Quick Access to Global Markets 01 04 Country Regulations Philippines Global Market Access 02 International Compliance Management Philippines Conformity Requirements Category Telecoms & Wireless Regulatory Agency Regulations National Telecommunications Commission (NTC) Terminal Equipment, or Customer Premises Equipment (CPE) and Radio Communications Equipment (RCE) require certification by NTC. CPE require type approval while RCE require type acceptance. Testing of all CPEs should be performed by Philippines Long Distance Telecommunications (PLDT) Company. Guidelines A local representative is required. Suppliers of CPE must be accredited by the NTC while RCE dealers need a permit. Certification Procedure: 1. Application and submission of essential documents For RCEs, test reports based on EN and FCC standards are accepted. 2. In-country product testing (not EMC: EMC compliance is required for the above, where applicable. 3. Evaluation required for RCEs) 4. Type Approval/Acceptance Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Philippines requirements and obtaining the necessary approvals. TÜV SÜD can also perform testing to EN and FCC standards for RCEs. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 94 Quick Access to Global Markets 01 04 Country Regulations Philippines Global Market Access 02 International Compliance Management Philippines Conformity Requirements Category Medical Device Regulatory Agency Regulations Bureau of Food and Drugs (BFAD) & Bureau of Health Devices and Technology (BHDT), Department of Health (DOH) Manufacturers need to obtain a License to Operate (LTO) and a Certificate of Product Registration (CPR) from BFAD. All foreign medical devices are required to undergo the same registration procedure and radiation-emitting devices must be registered with the DOH Radiation Health Office. Guidelines A local representative is required. A Free Sale Certificate or registration approval of the device from its country of origin is one of the essential documents required for registration. In the future, Philippines will be required to pass laws with the same provisions as the ASEAN Medical Device Directive (AMDD) – an overall regulation to harmonize medical device in ASEAN countries. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Philippines requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 95 Quick Access to Global Markets 01 04 Country Regulations Philippines Global Market Access 02 International Compliance Management Philippines Conformity Requirements Category Environmental Regulatory Agency Regulations Bureau of Product Standards (BPS), Department of Trade and Industry (DTI) Energy Efficiency: Guidelines Minimum Energy Performance Standards (MEPS) are required for certain products. Energy Efficiency Standards and Labelling Program require mandatory labelling for certain products. Application should be made to BPS for ENERGY GUIDE label. Products should comply with Philippine National Standards (PNS). Room air conditioners Refrigerators Freezers Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA Applicable Product Categories Product categories that require mandatory energy efficiency labelling include: • • • 03 • • Ballasts Compact fluorescent To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Philippines requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 05 TÜV SÜD Group 06 Quick Reference Overview 96 Quick Access to Global Markets 04 Country Regulations Singapore General Specifications Voltage Frequency Manual Language 230V (Single Phase); 400V (Three Phase) 50Hz English Regulatory Agency Regulations The Standards, Productivity Products deemed to be controlled goods are subject to and Innovation Board mandatory registration with SPRING Singapore under (SPRING Singapore) the CPS Scheme, and must bear the Safety Mark. Guidelines Safety Mark Procedure: 1. Register with Safety Authority to obtain valid Registered Suppliers (RS) code To be an RS, applicants must be a registered company in Singapore. Electrical Safety CPS Scheme – Consumer Protection (Safety Requirements) Regulations 2002 Registration is based on CoC issued by a designated third-party CAB. Factory inspections are not required. Compliance with SS and/or IEC standards. 2. Submit applications to a CAB for approval 3. Obtain CoC 4. Submit COC to SPRING Singapore and obtain Issue Acknowledgement Letter 5. Affix Safety Mark Applicable Product Categories Product categories requiring Safety Mark include: • • • Air-Conditioning Equipment Cleaning appliances Electrical accessories • • • Fans Home entertainment equipment Information technology equipment Global Market Access 02 International Compliance Management Singapore Conformity Requirements Category 01 • Kitchen appliances • Lighting • Personal care A full list of product categories may be found at http://www.spring.gov.sg/QualityStandards/CPS/Documents/List_of_controlled_goods.pdf To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Singapore requirements and obtaining the necessary approvals. TÜV SÜD is designated as a CAB by SPRING Singapore to issue CoC for all 45 controlled goods. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 97 Quick Access to Global Markets 01 04 Country Regulations Singapore Global Market Access 02 International Compliance Management Singapore Conformity Requirements Category Telecoms & Wireless Regulatory Agency Regulations Infocomm Development Authority (IDA) of Singapore All equipment must be approved by IDA by equipment registration. A registered Singapore company is required to obtain a Dealer’s License. There are 3 schemes under the equipment registration framework: Equipment Registration Procedure: Guidelines 1. Enhanced Simplified Equipment Registration (ESER) - online registration to indicate conformity based on suppliers’ own conformity assessment* 2. Simplified Equipment Registration (SER) – selfdeclaration of conformity based on suppliers’ own conformity assessment* 3. General Equipment Registration (GER) – declaration** certified by an IDA recognized CB OR declaration evaluated by IDA EMC: EMC compliance is required for the above, where applicable. Applicable Product Categories Equipment categories which can be registered under ESER Scheme: • Complex/Multi-line equipment • Short range/Low power Devices * ** 1. Online Equipment Registration 2. ESER – submit self-declaration and essential documents; complete online registration SER – complete self-declaration and submit essential documents; IDA will verify information GER – submit certificate issued by recognised CB and essential documents OR submit test results/reports and essential documents for approval Mandatory equipment categories under SER Scheme: • Mobile Terminals • Broadband Access Equipment 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview Suppliers’ own conformity assessment should be based on test results or evidence of equipment certification given by the manufacturer or an accredited body. A declaration to IDA is still required after certification by an IDA recognized CB. 98 Quick Access to Global Markets 01 04 Country Regulations Singapore Global Market Access 02 Singapore Conformity Requirements Applicable Product Categories Mandatory equipment categories under GER Scheme: • • • Land mobile radio Mobile base stations Wireless broadband access • • • Ultra-wideband Radio pager Short range devices, where the operation requires IDA approval To determine if a particular product is subject to the above regulations, please Contact Us TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Singapore requirements and obtaining the necessary approvals. As a designated CB, TÜV SÜD’s test reports and Certificate or Conformity is accepted for IDA approval. International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 99 Quick Access to Global Markets 01 04 Country Regulations Singapore Global Market Access 02 International Compliance Management Singapore Conformity Requirements Category Regulatory Agency Regulations Health Sciences Authority (HSA) From 1 May 2010, the sale of unregistered Class B, C, and D medical devices is prohibited. Registrants, or applicants, must be a registered Singapore company. By 1 May 2011, all medical devices will need to be registered in Singapore, and all dealers, including manufacturers and distributors, will need to be licensed with the HSA. Registered devices are listed on the Singapore Medical Device Register (SMDR). Medical Device Certification to GDPMDS* is required for all suppliers, to demonstrate the ability to maintain quality of medical devices throughout the supply chain; certification must be issued by HSA-recognized CB. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Singapore requirements and obtaining the necessary approvals. TÜV SÜD has a wide range of medical device testing and certification capabilities, and is accredited by SAC and recognized by HSA to certify to GDPMDS. * ** Good Distribution practice for medical devices in Singapore (GDPMDS) The founding members of Global Harmonization Task Force (GHTF) are Australia, Canada, the EU, Japan and the USA. Guidelines Registration of Class A devices requires only the submission of the product registration application. Registration of Class B, C, and D devices requires submission of a device dossier on top of the application. Companies with Class B, C, and D devices that already have market approval from founding members** of GHTF are allowed an “abridged” submission. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 100 Quick Access to Global Markets 01 04 Country Regulations Singapore Global Market Access 02 International Compliance Management Singapore Conformity Requirements Category Environmental Regulatory Agency Regulations National Environment Agency (NEA) Energy Efficiency: Suppliers who import or manufacture registrable goods are required to register themselves and such goods with NEA. Registrable goods must be affixed with the Energy Label, after the NEA has issued the Certificate of Registration (COR) for the model. Guidelines Application for registration of products can be made online. Suppliers need to maintain a technical file for each registered model during the validity period of the COR. Suppliers can appoint a third-party to register goods on their behalf. Applicable Product Categories Registrable goods include room air conditioners, refrigerators and clothes dryers. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Singapore requirements and obtaining the necessary approvals. TÜV SÜD is accredited by the Singapore Accreditation Council (SAC) to perform testing to the applicable test standards, and is able to support suppliers in registration. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 101 Quick Access to Global Markets 04 Country Regulations Taiwan General Specifications Voltage Frequency Manual Language 110V (Single Phase); 190V (Three Phase) 60Hz Traditional Chinese Electrical Safety Regulatory Agency Regulations Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs (MOEA) BSMI Safety Mark is mandatory for electrical and electronic products under the Commodity Inspection Act. Applicants must be a registered company in Taiwan. There are 4 inspection schemes to comply with product inspection requirements: • Type approval batch inspection (TABI) • Monitoring inspection (MI) • Registration of product certification (RPC)* • DoC The choice of the appropriate conformity assessment procedure is made depending on the characteristics of the product as well as other factors. Compliance with Chinese National Standards (CNS). Testing should be done by BSMI or designated test labs. EMC: EMC compliance is required for the above, where applicable. TABI – application with documentation and test reports are submitted to BSMI The RPC scheme is broken down into 7 modules of assessment and requires manufacturers to comply with any one or a combination of these modules. * Global Market Access 02 International Compliance Management Taiwan Conformity Requirements Category 01 Guidelines As a general guide: MI – a simplified batch-by-batch inspection system RPC – application with documentation and test reports are submitted to a designated CB DoC – application with DoC are submitted to BSMI; applicant maintains technical file 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 102 Quick Access to Global Markets 01 04 Country Regulations Taiwan Global Market Access 02 Taiwan Conformity Requirements Applicable Product Categories As of November 2004, 539 commodities are subject to mandatory inspection. Among them, 199 are chemical products and 340 are mechanical, electrical or electronic products. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Taiwan requirements and obtaining the necessary approvals. TÜV SÜD is a designated CB able to perform testing and issue Certification of Conformity (CoC) for a wide scope, supporting manufacturers in the applicable BSMI conformity assessment procedures. International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 103 Quick Access to Global Markets 01 04 Country Regulations Taiwan Global Market Access 02 International Compliance Management Taiwan Conformity Requirements Category Regulatory Agency Regulations National Communications Commission (NCC) A type approval scheme is followed. A local representative is required. The NCC Certification Mark should be affixed on the product after approval is granted. Most NCC-approved test labs are incountry, thus, test reports generated by foreign test labs will not be accept unless there are recognition agreements in place. Telecoms & Wireless Guidelines Testing must be conducted by a NCC-approved test lab. Type approval certificate is issued by a NCC-approved CB. EMC NCC EMC compliance is required for the above, where applicable. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Taiwan requirements and obtaining the necessary approvals. As a NCC-approved test lab, TÜV SÜD is able to perform the required testing to compliance and support manufacturers in obtaining the NCC certification mark. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 104 Quick Access to Global Markets 01 04 Country Regulations Taiwan Global Market Access 02 International Compliance Management Taiwan Conformity Requirements Category Medical Device Regulatory Agency Regulations Division of Medical Devices Since 1 January 2010, the original Bureau of and Cosmetics, Food Pharmaceutical Affairs (BPA) has been replaced by the and Drug Administration, Division of Medical Devices and Cosmetics. Department of Health (DOH) The Pharmaceutical Affairs Law (PAL) regulates all medical devices. Most devices need to meet the Good Manufacturing Practice (GMP) requirement based on the ISO 13485. Pre-Market Approval* (PMA) is required for most Class II, and all Class III devices. Guidelines A local representative is required. Companies dealing with medical devices are required to submit the application for GMP and product registration. Inspection may be conducted on-site or through Quality System Documentation (QSD) review. Device classification is similar to that of US FDA. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Taiwan requirements and obtaining the necessary approvals. * The DOH is gradually simplifying requirements and actively seeking to harmonize domestic regulations with international practices on pre-market approval of medical devices. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 105 Quick Access to Global Markets 01 04 Country Regulations Taiwan Global Market Access 02 International Compliance Management Taiwan Conformity Requirements Category Environmental Regulatory Agency Regulations Bureau of Energy (BOE), Ministry of Economic Affairs (MOEA) Energy Efficiency: Minimum Energy Performance Standards (MEPS) are required for many products. Guidelines After passing testing for compliance with certain standards, applicants may attach Energy Labels to products. Voluntary government-backed labelling through Energy Conservation Label. From 1 July 2010, BSMI requires mandatory labelling for room air conditioners and refrigerator-freezers. Applicable Product Categories A full list of product categories may be found at http://www.energylabel.org.tw/application_en/efficiency/list.asp To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Taiwan requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 106 Quick Access to Global Markets 04 Country Regulations Thailand General Specifications Voltage Frequency Manual Language 220V (Single Phase); 380V (Three Phase) 50Hz Thai/English Regulatory Agency Regulations Thai Industrial Standards Institute (TISI), Ministry of Industry Products regulated under the Industrial Product Standards Act are required to be affixed with the TIS Mark. Products under the mandatory list need to comply with product safety standards and factory quality control system requirements before affixing the mandatory TIS Mark. Assessment of quality control system usually involves a factory inspection or similar indications of conformance. Testing of product samples need to be performed by properly accredited/approved test labs. Other products may also obtain the voluntary TIS Mark. Compliance with TIS standards. Electrical Safety Global Market Access 02 International Compliance Management Thailand Conformity Requirements Category 01 Guidelines A Local Representative is required for application. Approval Procedure: 1.Application 2. Assessment of quality control system 3. Evaluation of products 4. Obtain TISI certificate 5.Labelling 6.Surveillance Applicable Product Categories A full mandatory list of product categories may be found at http://app.tisi.go.th/standard/comp_eng.html To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Thailand requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview As a listed testing lab for Thailand under the ASEAN EE MRA, TÜV SÜD’s test reports are accepted by TISI for safety approval. 107 Quick Access to Global Markets 01 04 Country Regulations Thailand Global Market Access 02 International Compliance Management Thailand Conformity Requirements Category Regulatory Agency Regulations National Telecommunications Commission (NTC) Equipment which falls in the mandatory scope requires NTC approval. Telecoms & Wireless There are 3 types of equipment classification which have different type of Conformity Assessment procedures. Class A equipment requires testing by the office of NTC, certification from NTC and labelling. Class B equipment follows the same procedure as Class A but NTC accepts test reports based on international test standards* by a properly accredited test lab. SDoC equipment requires an issuance of a DoC to NTC, labelling is not required. EMC: EMC compliance is required for the above, where applicable. Applicable Product Categories Class A includes: • GMPCS/ microwave fixed links Class B includes: • Maritime/ Aero nautical • Land mobile VHF/UHF • High-power RFID/ Vehicle radar. * SDoC includes: • Low power device/ Short range devices • WLAN/ Radio control • Telecommunications terminal equipment Guidelines A local representative is required. Approval Procedure for Class A and B: 1. File application 2. Type approval based on testing of sample (Class A), or recognition of test report (Class B). 3. Obtain NTC approval 4. Label products appropriately DoC Procedure: 1. Submit DoC, test report and essential documents to NTC for approval 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview International test standards include FCC, ETSI/EN standards 108 Quick Access to Global Markets 01 04 Country Regulations Thailand Global Market Access 02 Thailand Conformity Requirements Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Thailand requirements and obtaining the necessary approvals. As an accredited test lab, TÜV SÜD can perform testing to international test standards that is accepted for Class B equipment. International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 109 Quick Access to Global Markets 01 04 Country Regulations Thailand Global Market Access 02 International Compliance Management Thailand Conformity Requirements Category Regulatory Agency Regulations Medical Device Control Division, Thai Food and Drug Administration (FDA) General control is required for Category I devices. Medical Device Pre-marketing notification is required for Category II devices. Pre-marketing approval is required for Category III devices. All devices need to be labelled appropriately. Post-marketing control is conducted. Guidelines General Control: Submission of Certificate of Free Sale is required. Pre-marketing notification: Submission of detailed product information and CFS is required. Pre-marketing approval: Registration and license in compliance with Ministerial Regulations is required. In the future, Thailand will be required to pass laws with the same provisions as the ASEAN Medical Device Directive (AMDD) – an overall regulation to harmonize medical device in ASEAN countries. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Thailand requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 110 Quick Access to Global Markets 01 04 Country Regulations Thailand Global Market Access 02 International Compliance Management Thailand Conformity Requirements Category Environmental Regulatory Agency Regulations Electricity Generating Authority of Thailand (EGAT) Energy Efficiency: Minimum Energy Performance Standards (MEPS) are required for certain products. Mandatory labelling required for refrigerators and refrigerator-freezers under the Energy Efficient Refrigerator Program. Guidelines Manufacturers are required to test products for labelling. Voluntary labelling is recommended for other products under EGAT’s Demand Side Management Program. Mandatory labelling required for compact fluorescent lamps under Energy Efficiency No.5 Label. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Thailand requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 111 Quick Access to Global Markets 04 Country Regulations Vietnam General Specifications Voltage Frequency Manual Language 220V (Single Phase); 380V (Three Phase) 50Hz Vietnamese/English Regulatory Agency Regulations Directorate for Standards, Metrology and Quality (STAMEQ) Locally manufactured regulated products require mandatory certification and Vietnam Certification Centre (QUACERT) quality mark. Imported products are regulated by import-export goods control and only require a DoC or certification by a third-party CB. Compliance with TCVN and/or IEC standards Electrical Safety Global Market Access 02 International Compliance Management Vietnam Conformity Requirements Category 01 Guidelines Certification Procedure: 1. Testing by designated test lab 2. Submission of application and essential documents 3. STAMEQ assessment 4. Certification 5.Surveillance Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Vietnam requirements and obtaining the necessary approvals. As a listed CB for Vietnam under the ASEAN EE MRA, TÜV SÜD’s test reports are accepted by QUACERT for certification. TÜV SÜD can also perform testing and certification for imported products. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 112 Quick Access to Global Markets 01 04 Country Regulations Vietnam Global Market Access 02 International Compliance Management Vietnam Conformity Requirements Category Regulatory Agency Directorate of Information and Communication Technology Quality Control, Ministry of Information and Telecoms & Wireless Communications (MIC) in Vietnam Regulations Guidelines Depending on the product, type approval by certification or DoC is required. Testing for type approval should be performed by test labs approved and listed by the MIC. Products approved or declared should be labelled appropriately with ICT Mark of conformity. A local representative is required. Certification Procedure: 1. Sample testing 2. Submission of application, test reports and essential documents 3. Certification 4. Product labelling EMC: EMC compliance is required for the above, where applicable. DoC Procedure: 1. Sample testing* 2. Submit DoC and essential documents 3. Acknowledgement of DoC 4. Product labelling Applicable Product Categories Product categories subject to mandatory type approval include: • Fixed, mobile network elements • Transmission Equipment • Transmission Cable • Terminal Equipment * 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 • • RF transmitters, transceivers, from 9kHz to 400GHz and transmitted power greater than 60mW Radio frequency support equipment Quick Reference Overview For DoC, test report to EN standards is also accepted. 113 Quick Access to Global Markets 01 04 Country Regulations Vietnam Global Market Access 02 Vietnam Conformity Requirements Applicable Product Categories Product categories subject to standards that may use DoC, or type approval, include: • Cable connected box • Hub • Desktop person computer, Server • Switch • Notebook and portable computer • Gateway • Personal Digital Assistant • Bridge • Router • Firewall To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Vietnam requirements and obtaining the necessary approvals. TÜV SÜD is also an accredited test lab able to perform testing to applicable standards for DoC. International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 114 Quick Access to Global Markets 01 04 Country Regulations Vietnam Global Market Access 02 International Compliance Management Vietnam Conformity Requirements Category Regulatory Agency Regulations Ministry of Health (MOH) Domestic devices generally require product registration. Medical Device Imported medical devices do not require product registration, but require an import license. Though unclear, there is indication that only medical devices that are allowed in their country of origin may be considered for import into Vietnam. Only Vietnamese companies are allowed to distribute medical devices in Vietnam. Guidelines Usually a Free Sale Certificate from the device’s country of origin is required for import. License application procedures require that a sample of any new equipment be brought into Vietnam for clinical testing* by medical or healthcare establishments In the future, Vietnam will be required to pass laws with the same provisions as the ASEAN Medical Device Directive (AMDD) – an overall regulation to harmonize medical device in ASEAN countries. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Vietnam requirements and obtaining the necessary approvals. * Waivers may be available for equipment of a size and cost that would make it impractical to transport and install as a sample for testing. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 115 Quick Access to Global Markets 01 04 Country Regulations Vietnam Global Market Access 02 International Compliance Management Vietnam Conformity Requirements Category Environmental Regulatory Agency Regulations Ministry of Industry and Trade Energy Efficiency: The energy standards and labelling program is still in the early stages. Currently, the Vietnam National Energy Efficiency and Conservation Project (VNEEP) is still under consideration. Guidelines In the future, compliance with Minimum Energy Performance Standards (MEPS) and energy efficiency labelling will be required for certain products. Applicable Product Categories Energy saving labelling program is being worked out for products including compact fluorescent lamps, T8 fluorescent tube lamps (FTLs), high pressure sodium lamps, magnetic ballasts and electronic ballasts of FTLs. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Vietnam requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 116 Quick Access to Global Markets 04 Country Regulations Israel General Specifications Voltage Frequency Manual Language 230V (Single Phase); 400V (Three Phase) 50Hz Hebrew/English Regulatory Agency Regulations Standards Institution of Israel (SII) Electrical product safety testing is mandatory, and manufacturers are required to obtain SII test certificate to import products into Israel. Manufacturers may also choose to apply for the SII mark in order to apply the SII Safety Mark on products. Compliance with SI standards. EMC: EMC compliance is required for electrical products, telecoms and wireless equipment, where applicable. Electrical Safety Global Market Access 02 International Compliance Management Israel Conformity Requirements Category 01 Guidelines A local representative is required. Approval is granted based on review of CB test reports, but in-country testing is often required. For SII test certificate, no factory inspection is required and no mark will be granted. For SII mark, pre-license factory inspection is required and the SII Safety Mark will be granted. Applicable Product Categories It is mandatory for any product, to which an existing formal Israeli Standard applies, to be tested for compliance with the particular standard. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Israel requirements and obtaining the necessary approvals. As a CB Scheme member, TÜV SÜD’s test reports can be used as a reference and may reduce the amount of local testing. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 117 Quick Access to Global Markets 01 04 Country Regulations Israel Global Market Access 02 International Compliance Management Israel Conformity Requirements Category Regulatory Agency Regulations Ministry of Communications Equipment connected to the public network requires (MoC) Israel type approval from MoC. Telecoms Guidelines A local representative is required. Approval can often be issued based on review of foreign standard test reports without in-country testing. A local representative is required. Wireless MoC Israel Radio terminal devices require approval from MoC. The approval process includes review of foreign standard test reports, but MoC may require additional testing and/or inspection sample(s) of the equipment. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Israel requirements and obtaining the necessary approvals. As a CB Scheme member, TÜV SÜD is able to perform testing to international standards acceptable for MoC approval. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 118 Quick Access to Global Markets 01 04 Country Regulations Israel Global Market Access 02 International Compliance Management Israel Conformity Requirements Category Regulatory Agency Regulations Israel’s Ministry of Health (IMOH) All medical devices, including biologics, must be registered with IMOH. Medical Device IMOH recognizes US FDA certification and the EU CE Mark, and usually approves products carrying such certifications without further requirements. Importers also require a pre-marketing approval from IMOH, for which US FDA 510(K) or PMA, CE Mark, or Canadian documentation is required. Guidelines A local representative is required. For imported devices, application for registration should include (if available) a certificate issued by a competent authority of one of the following countries: Australia, Canada, EU, Japan, or USA. If such a certificate is not available, the registration process is still available but will take a longer time, and MOH will determine what type of testing is required. Apart from appropriate safety certification, other essential documentation and DoC should be submitted to IMOH. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Israel requirements and obtaining the necessary approvals. 06 Quick Reference Overview 119 Quick Access to Global Markets 01 04 Country Regulations Israel Global Market Access 02 International Compliance Management Israel Conformity Requirements Category Regulatory Agency Regulations Ministry of National Infrastructures Energy Efficiency: Environmental Minimum Energy Performance Standards (MEPS) are required for certain products. Guidelines Labelling requirement is based on minimum power consumption Mandatory energy efficiency labelling is also required for certain products. Applicable Product Categories Product categories that require mandatory energy efficiency labelling include: • Air conditioners • Refrigerators • Cooktops and ranges/Ovens To determine if a particular product is subject to the above regulations, please Contact Us TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Israel requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 120 Quick Access to Global Markets 04 Country Regulations Kuwait General Specifications Voltage Frequency Manual Language 240V (Single Phase); 415V (Three Phase) 50Hz Arabic/English Electrical Safety Regulatory Agency Regulations Public Authority for Industry The Kuwait Conformity Assurance Scheme (KUCAS) (PAI) is a set of procedures carried out by PAI to verify the conformity of all ‘Regulated Products’ (domestic or imported) to Kuwait’s Technical Regulations and approved Standards. Manufacturers with consignments of regulated products to be shipped to Kuwait are required to complete the conformity procedures prior to shipment through one of the Certification and Inspection Bodies (CIB) approved by PAI. A Technical Evaluation Report (TER) and a Technical Inspection Report (TIR) issued by approved CIB are required. Compliance with KSS and IEC standards. Global Market Access 02 International Compliance Management Kuwait Conformity Requirements Category 01 Guidelines Manufacturers need to be licensed. The TER is issued by an approved CIB on the basis of successful type testing or test report evaluation. Inspection and testing (based on risk assessment and type of product) would be conducted prior to shipment by the relevant CIB for TIR. Applicable Product Categories A full list of regulated product categories may be found at http://www.pai-kucas.com/regulatedproducts/ To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Kuwait requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 121 Quick Access to Global Markets 01 04 Country Regulations Kuwait Global Market Access 02 International Compliance Management Kuwait Conformity Requirements Category Regulatory Agency Regulations Ministry of Communications The Ministry of Communications issues type approval Kuwait for terminal equipment. Telecoms & Wireless Guidelines A local representative is required. Approval is based on review of foreign standard test reports. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Kuwait requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 122 Quick Access to Global Markets 01 04 Country Regulations Kuwait Global Market Access 02 International Compliance Management Kuwait Conformity Requirements Category Regulatory Agency Regulations Ministry of Health A special license from Ministry of Health is required. Medical Device Guidelines All products must comply with the Kuwaiti standards (KSS) and if there are no specific standards to be applied, then the Gulf countries’ standards must be established. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Kuwait requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 123 Quick Access to Global Markets 01 04 Country Regulations Kuwait Global Market Access 02 International Compliance Management Kuwait Conformity Requirements Category Environmental Regulatory Agency Regulations American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) Energy Efficiency: Standard 90.2 for residential energy conservation has been adapted to use. Guidelines The standard has been adapted to include some portions of ASHRAE standards 90.1 and ASHRAE standard 62.2. Applicable Product Categories Product categories that require mandatory energy efficiency labelling include: • Air conditioners To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Kuwait requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 124 Quick Access to Global Markets 04 Country Regulations Saudi Arabia General Specifications Voltage Frequency Manual Language 127V / 220V (Single Phase); 220V / 380V (Three Phase) 60Hz Arabic/English Electrical Safety Regulatory Agency Regulations Ministry of Industry and Commerce (MOCI) & Saudi Arabian Standards Organization (SASO) Imported products are subject to SASO Certification Program (ICCP). CoC, issued by an entity authorized by the competent official agency in the country of origin, is required for all imported regulated products. Every new shipment requires Certificate of Registration (CoR) and CoC. Repeat applications (same product) with a valid CoR will expedite the issuance of CoC. Testing by an accredited test lab is required. All imported consignments must bear a non-removable indication of origin. Compliance with SASO and IEC standards. SASO Global Market Access 02 International Compliance Management Saudi Arabia Conformity Requirements Category 01 Guidelines Pre-shipment Inspection (PSI) is required for CoC. The authorities in Saudi Arabia may also take random samples from imported consignments to verify compliance. In the event that a shipment arrives at any Saudi Arabia port without a CoC, the shipment will either be rejected or require product testing by an approved local test lab. EMC compliance is required for the above, for products with telecommunication function. EMC Applicable Product Categories Regulated products include all consumer products arriving in Saudi Arabia, except military equipment, medical products and food. To determine if a particular product is subject to the above regulations, please Contact Us. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Saudi Arabia requirements and obtaining the necessary approvals. TÜV SÜD is eligible to issue Certificate of Registration (CoR) and CoC for products imported into the Kingdom of Saudi Arabia. 125 Quick Access to Global Markets 01 04 Country Regulations Saudi Arabia Global Market Access 02 International Compliance Management Saudi Arabia Conformity Requirements Category Telecoms & Wireless Regulatory Agency Regulations Communications and Information Technology Commission (CITC) CITC Interim Authorization for imported telecommunications and wireless equipment is required. This is in lieu of a type approval procedure while the commission’s new procedures are pending. Guidelines CITC’s Interim Authorization is based upon review of existing foreign standard test reports such as EN or FCC test reports. The Commission may obtain a sample of the equipment held by the Authority for testing to verify conformance to the Commission’s requirements. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Saudi Arabia requirements and obtaining the necessary approvals. TÜV SÜD can perform EN and FCC testing for CITC Interim Authorization. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 126 Quick Access to Global Markets 01 04 Country Regulations Saudi Arabia Global Market Access 02 International Compliance Management Saudi Arabia Conformity Requirements Category Medical Device Regulatory Agency Regulations Saudi Food & Drug Authority (SFDA) SFDA is about to embark on an Interim Marketing Authorization Regulation* to regulate all medical devices. All manufacturers are required to register themselves and medical devices in the Medical Devices National Registry (MDNR) before applying for the Medical Devices Establishment License (MDEL). Guidelines A local representative is required. SFDA will grant a written Medical Devices Marketing Authorization to manufacturers upon approval. The SFDA will launch the electronic registration system soon. Applicable Product Categories Product categories under the Interim Marketing Authorization Regulation include: • All Medical Devices and their accessories • Contact lenses and laser surgical equipment for cosmetic rather than medical purposes, and their accessories. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Saudi Arabia requirements and obtaining the necessary approvals. * The Interim Marketing Authorisation Regulation and its implementing rules will be published soon in the official news paper and on the SFDA website. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 127 Quick Access to Global Markets 01 04 Country Regulations Saudi Arabia Global Market Access 02 International Compliance Management Saudi Arabia Conformity Requirements Category Environmental Regulatory Agency Regulations Ministry of Industry and Commerce (MOCI) & Saudi Arabian Standards Organization (SASO) Energy Efficiency: Minimum Energy Performance Standards (MEPS) is required for non-ducted air conditioners and heat pumps. Energy Efficiency Labelling Regulation is mandatory from April 2010 for certain products. Guidelines Each product model is required to be registered with SASO and labelled with an energy efficiency rating. The rating will be assigned based on the results of energy performance tests according to recently approved SASO standards. Appliances will be assigned a rating of one to six stars; the greater the number of stars, the higher the energy efficiency. Applicable Product Categories Product categories that require mandatory energy efficiency labelling include air conditioners, refrigerators and freezers, and washing machines. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with Saudi Arabia requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 128 Quick Access to Global Markets 04 Country Regulations United Arab Emirates General Specifications Voltage 240V / 220V (Single Phase); Frequency Manual Language 50Hz Arabic/English Electrical Safety Regulatory Agency Regulations Emirates Authority for Standardization and Metrology (ESMA) Under the Emirates Conformity Assessment Scheme (ECAS), registration of regulated products is required. Currently only “Household Electrical Water Heaters” are regulated. ESMA will issue an ECAS Registration Certificate for the product when conformity to the relevant standards is demonstrated. Manufacturers may also request for the Emirates Quality Mark. Global Market Access 02 International Compliance Management United Arab Emirates Conformity Requirements Category 01 Guidelines Assessment, testing and evaluation of products should be conducted by ESMA or its recognized CABs. Product sampling is required and must be conducted by ESMA authorized personnel. Applicable Product Categories More information regarding regulated product categories may be found at http://www.esma.ae/lang-en/ecas/ecas-pro To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with UAE requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 129 Quick Access to Global Markets 01 04 Country Regulations United Arab Emirates Global Market Access 02 International Compliance Management United Arab Emirates Conformity Requirements Category Regulatory Agency Regulations Telecommunications Regulatory Authority (TRA) TRA requires approval of radio equipment and telecommunications terminal equipment to comply with relevant technical specifications. Telecoms & Wireless Guidelines A local representative is required. Equipment need to be registered with the TRA before it can be supplied in the UAE. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with UAE requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 130 Quick Access to Global Markets 01 04 Country Regulations United Arab Emirates Global Market Access 02 International Compliance Management United Arab Emirates Conformity Requirements Category Medical Device Regulatory Agency Regulations Ministry of Health Drug Control Department Companies both (domestic and foreign) and their distributors (importers) of medical devices must register their establishments with the Drug Control Department. Companies who wants to export medical devices to UAE must have a local UAE representative or distributor who holds Medical Store licensed from Ministry of Health. All manufacturers of Class I, Class II a, Class II b, Class III and Active Implantable Devices has to be registered with UAE Ministry of Health. Guidelines Devices shall be divided into Class I, Class II a, Class II b, Class III. The committee on Medical Device registration will decide to approve its registration through one or two stages. Registration of MD must be made by the device manufacturer or local authorized representative. The committee will briefly review the MD and decide if exempted from further evaluation or require more documents. When the MD passes all the requirements and obtained approval from committee, it will be granted a registration certificate and will be valid for 5 years. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with UAE requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 131 Quick Access to Global Markets 01 04 Country Regulations United Arab Emirates Global Market Access 02 International Compliance Management United Arab Emirates Conformity Requirements Category Regulatory Agency Regulations Emirates Authority for Standardization and Metrology (ESMA) Energy Efficiency: A new energy efficiency labelling programme will come into effect by the end of 2010. Environmental Guidelines The certification, that is to be placed on all electronic goods imported or manufactured in the country, aims to ensure that gadgets adhere to a set standard for the main purpose of energy conservation. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with UAE requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 132 Quick Access to Global Markets 04 Country Regulations South Africa General Specifications Voltage Frequency Manual Language 230V (Single Phase); 400V (Three Phase) 50Hz English Regulatory Agency Regulations National Regulator for Compulsory Specifications (NRCS) Letter of Authority (LoA) is required by manufacturers of products under mandatory standards upon conformity assessment. Test report must be from a test lab by a national accreditation body affiliated to the International Laboratory Accreditation Cooperation (ILAC) and/or be an IECEE CB Scheme member. On top of LoA, manufacturers of regulated products may choose to obtain South African Bureau of Standards (SABS) Mark. Compliance with SANS and/or IEC standards. Electrical Safety Global Market Access 02 International Compliance Management South Africa Conformity Requirements Category 01 Guidelines Manufacturers are first required to register with NRCS Electrotechnical Department before LOA will be issued. LoA Procedure: 1.Application 2. Submission of test report and essential documents 3.Review 4. Issuance of LoA A local representative is required if manufacturers choose to obtain SABS Mark. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with South Africa requirements and obtaining the necessary approvals. As a CB Scheme member, TÜV SÜD can also perform testing to applicable standards for safety approval. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 133 Quick Access to Global Markets 01 04 Country Regulations South Africa Global Market Access 02 International Compliance Management South Africa Conformity Requirements Category Regulatory Agency Regulations Independent Communications Authority of South Africa (ICASA) Type Approval is required for regulated equipment. Type Approval Procedure: ICASA accept test reports against the relevant EN standards, providing the testing has been performed at an accredited test facility. 1. Submission of application, test reports and essential documents Telecoms & Wireless Guidelines 2.Review National Regulator for Compulsory Specifications (NRCS) EMC compliance is required for the above, where applicable. 3. Issuance of Type Approval 4. Labelling as appropriate CoC for EMC is required for some equipment. EMC Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with South Africa requirements and obtaining the necessary approvals. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 134 Quick Access to Global Markets 01 04 Country Regulations South Africa Global Market Access 02 International Compliance Management South Africa Conformity Requirements Category Regulatory Agency Regulations Department of Health (DOH) Medical equipment – other than electro medical devices – including disposable or single use devices, is not regulated*. Medical Device Electromagnetic medical devices (or radiation emitting devices) must be registered with the DOH, and must carry the CE mark. All importers must apply for a license from the DOH, Directorate: Radiation Control. Guidelines The South African Department of Health is currently in the process of drafting the necessary policy documents and has indicated that these may become available some time in the future. Applicable Product Categories To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with South Africa requirements and obtaining the necessary approvals. * Despite the lack of regulations, it is strongly advisable that the product be FDA (USA) approved, or even better, carry the EU CE marking. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 135 Quick Access to Global Markets 01 04 Country Regulations South Africa Global Market Access 02 International Compliance Management South Africa Conformity Requirements Category Environmental Regulatory Agency Regulations Department of Minerals and Energy Energy Efficiency: Minimum Energy Performance Standards (MEPS) for certain products are still under consideration. Energy labelling will be applicable to all electrical household articles. The initial labels are set to be attached voluntarily to some products, while compulsory labelling will take effect in the near future. Guidelines The standards are divided into 7 categories with A representing the most efficient appliance and G representing the least efficient appliance. Applicable Product Categories Energy labelling is currently voluntary for refrigerators and freezers. To determine if a particular product is subject to the above regulations, please Contact Us. TÜV SÜD Solutions TÜV SÜD has the experience and capability to support manufacturers in attaining compliance with South Africa requirements and obtaining the necessary approvals. TÜV SÜD can also support manufacturers in obtaining voluntary endorsement labels. 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 136 Quick Access to Global Markets 01 05 TÜV SÜD Group Today’s competitive business environment is driven by speed, price, innovation, quality and safety. TÜV SÜD is the leading technical solutions partner that will support you with the right business tools, expertise and experience. At TÜV SÜD, we will help you deliver world class products and services to access your key international markets. With us, you achieve and retain a competitive edge. Partnering TÜV SÜD offers tangible economic benefits: • • • • • • • • Shorter time-to-market Increased international market access Improved product and process quality and safety Reduced costs and inefficiencies Increased productivity and profit Minimised business risks Brand reputation gain ...plus a commitment towards environmental protection and the social welfare of employees Global Market Access Why choose TÜV SÜD? For over 140 years, TÜV SÜD has built itself a solid reputation for world class service and cutting edge German know-how. TÜV SÜD provides testing, inspection, certification, training and knowledge services to achieve the optimisation of technology, systems and expertise. • Impartial and independent • Sterling brand reputation • Multidisciplinary and customized solution oriented approach • Solid global knowledge base on market regulations – standards, testing and conformity requirements • One-stop certification partner – participant in the IECEE CB Scheme recognized in over 50 countries; over 100 accreditations currently held worldwide • Extensive global pool of experience – over 15,000 skilled employees; more than 150,000 product certifications and 35,000 management system certificates issued to date • Accessibility – 600 locations and extensive laboratory network worldwide • Support from A-Z – from design to delivery or dismantling, offers holistic solutions along the entire business process 02 International Compliance Management 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 137 Quick Access to Global Markets 01 05 TÜV SÜD Group Global Market Access 02 TÜV SÜD’s global presence and expertise TÜV SÜD supports industries from A-Z International Compliance Management 03 Application of the Guidebook 04 TÜV SÜD’s holistic service solutions for the entire business process Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 138 Quick Access to Global Markets 01 06 Quick Reference Overview Global Market Access 02 International Compliance Management Mandatory Conformity Requirements as of Aug 2010 Country Electrical Safety Telecoms Wireless Medical Device Environmental Europe European Union CE Marking CE Marking CE Marking CE Marking CE Marking, Energy Efficiency Labelling, WEEE & RoHS compliance Russia GOST-R Approval & SanitaryEpidemiological Conclusion Certificate FAC Approval FAC Approval Federal Service for Control over Healthcare and Social Development Registration Certificate Energy Efficiency Labelling Argentina S-Mark CNC Approval CNC Approval ANMAT Registration Energy Efficiency Labelling Brazil INMETRO Mark ANATEL Approval ANATEL Approval ANVISA Registration PROCEL Labelling Program and MEPS Canada SCC Certification IC Approval IC Certification Health Canada Registration EnerGuide Labelling Program, MEPS & WEEE compliance Mexico NOM Certification COFETEL Certification COFETEL Certification Mexican Secretariat of Health Registration Energy Efficiency Labelling & MEPS United States of America NRTL Certification ACTA Approval FCC Approval FDA Approval EnergyGuide Labelling, MEPS & Californian RoHS compliance The Americas 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 139 Quick Access to Global Markets 01 06 Quick Reference Overview Global Market Access 02 International Compliance Management Mandatory Conformity Requirements as of Aug 2010 Country Electrical Safety Telecoms Wireless Medical Device Environmental Australasia Australia CoA or RCM A-Tick Mark C-Tick Mark ARTG Inclusion Star Rating Label Scheme & MEPS New Zealand CoA or RCM Telepermit C-Tick Mark WAND Notification Star Rating Label Scheme & MEPS Asia Brunei Darussalam DES Registration AITI Approval AITI Approval NA NA Cambodia ISC Certification MPTC Approval MPTC Approval NA NA China CCC Mark NAL Certification SRRC Approval SFDA Registration China Energy Label Registration, MEPS & RoHS compliance Hong Kong EMSD Certification OFTA Certification OFTA Certification MDCO Registration EELS India ISI Certification TEC Approval WPC Approval CDCSO Approval Star Label Indonesia SNI Mark DGPT Approval DGPT Approval Directorate for Drug and Medical Devices Control Registration NA 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 140 Quick Access to Global Markets 01 06 Quick Reference Overview Global Market Access 02 International Compliance Management Mandatory Conformity Requirements as of Aug 2010 Country Electrical Safety Telecoms Wireless Medical Device Environmental Asia Japan PSE Mark MIC Approval MIC Approval MHLW Approval Top Runner Program, Energy-saving Labelling Program, WEEE & RoHS compliance Korea (South) KC Mark KCC Mark KCC Mark KFDA Registration Energy Efficiency Labelling & MEPS, WEEE & RoHS compliance Malaysia SIRIM Label or Certification Mark MCMC Approval MCMC Approval MDB Registration MEPS Philippines PS Certification or ICC Mark Philippines NTC Certification Philippines NTC Certification BFAD Registration Energy Efficiency Labelling & MEPS Singapore CPS Scheme Safety Mark IDA Equipment Registration IDA Equipment Registration HSA Registration NEA Registration Taiwan BSMI Mark NCC Approval NCC Approval Taiwan DOH Registration Energy Efficiency Labelling & MEPS Thailand TIS Mark Thai NTC Approval Thai NTC Approval Thai FDA Approval Energy Efficiency Labelling & MEPS Vietnam STAMEQ Approval (for domestic products only) ICT Mark ICT Mark MOH Registration NA 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview 141 Quick Access to Global Markets 01 06 Quick Reference Overview Global Market Access 02 International Compliance Management Mandatory Conformity Requirements as of Aug 2010 Country Electrical Safety Telecoms Wireless Medical Device Environmental Middle East Israel SII Certificate MoC Approval MoC Approval IMOH Registration Energy Efficiency Labelling & MEPS Kuwait TER & TIR Ministry of Communications Kuwait Approval Ministry of Communications Kuwait Approval Ministry of Health American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE) Saudi Arabia SASO Certificate CITC Interim Authorization CITC Interim Authorization SFDA Authorization Energy Efficiency Labelling & MEPS United Arab Emirates ECAS Registration Certificate TRA Approval TRA Approval Ministry of Health Drug Control Department Emirates Authority for Standardization and Metrology (ESMA) NRCS LoA ICASA Approval ICASA Approval South Africa DOH Registration Energy Efficiency Labelling & MEPS Africa South Africa 03 Application of the Guidebook 04 Country Regulations Africa Asia Pacific Europe Middle East NAFTA 05 TÜV SÜD Group 06 Quick Reference Overview Disclaimer: This table overview serves only as a guide for country conformity requirements. For more information, please contact your local TÜV SÜD expert. 142 Quick Access to Global Markets Index A C Administrative Council for Terminal Attachments (ACTA) 35 Agência Nacional de Telecomunicações (ANATEL) 23 Agencia Nacional Vigilancia de Sanitaria (ANVISA) 24 ANCE30 A-Tick Mark 40 Australian Communications & Media Authority (ACMA) 40 Australian Greenhouse Office 43 Authorities Having Jurisdiction (AHJ) 26, 34 Authority for Info-communications Technology Industry (AITI) 50 CCC Mark 57, 58, 61 CE Marking 11, 12, 13, 16, 135 Central Drugs Standard Control 72 Central License Approving Authority (CLAA) 72 Certification and Accreditation Administration of the People’s Republic of China (CNCA) 57 China National Institute of Standardization (CNIS) 62 China Quality Certification Centre (CQC) 57 Comisión Federal de Telecomunicaciones (COFETEL) 31 Comisión Nacional de Comunicaciones (CNC) 19 Comisión Nacional para el Ahorro de Energia (CONAE), Energy Secretariat 33 Communications and Information Technology Commission (CITC) 126 C-Tick Mark 41, 46 B Brazilian National Health Surveillance Agency See Agencia Nacional Vigilancia de Sanitaria (ANVISA) 24 BSMI Safety Mark 102 Bureau of Energy (BOE), Ministry of Economic Affairs (MOEA) 106 Bureau of Energy Efficiency (BEE), Ministry of Power 73 Bureau of Food and Drugs (BFAD) 95 Bureau of Health Devices and Technology (BHDT), Department of Health (DOH)95 Bureau of Indian Standards (BIS), Ministry of Consumer Affairs, Food & Product Distribution 69 Bureau of Pharmaceutical Affairs (BPA) 105 Bureau of Product Standards (BPS), Department of Trade and Industry (DTI) 93, 96 Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs (MOEA) 102 D Department of Electrical Services (DES, Prime Minister Office) Department of Health (DOH) Department of Minerals and Energy Directorate for Drug and Medical Devices Control, Ministry of Health Republic of Indonesia Directorate for Standards, Metrology and Quality (STAMEQ) Directorate General of Electricity and Energy Utilization Directorate General of Posts and Telecommunications (DGPT) Directorate of Information and Communication Technology Quality Control, Ministry of Information and Communications (MIC) in Vietnam 49 135 136 76 112 77 75 113 143 Quick Access to Global Markets Division of Medical Devices and Cosmetics, Food and Drug Administration, Department of Health (DOH) 105 E Electrical & Mechanical Services Department (EMSD) Electrical & Mechanical Services Department (EMSD), Government of the Hong Kong Special Administrative Region Electrical Regulatory Authorities Council (ERAC) Electricity Generating Authority of Thailand (EGAT) Emirates Authority for Standardization and Metrology (ESMA) Energy Efficiency and Conservation Authority (ECCA) Energy Labelling and Standards Task Force of Energy Division, Prime Minister’s Office European Commission (EC) 68 64 39, 44 111 129, 132 48 52 11 F Federal Agency of Communications (FAC) 15 Federal Agency on Technical Regulating and Metrology 14, 17 Federal Communications Commission (FCC) 35 Federal Service for Control over Healthcare and Social Development, Roszdravnadzor16 Federal Trade Compliance (FTC) 38 Food and Drug Administration (FDA) 37 H Health Canada Health Sciences Authority (HSA) 28 100 I ICT Mark Import Commodity Clearance (ICC) Certification Mark Independent Communications Authority of South Africa (ICASA) Industry Canada (IC) Infocomm Development Authority (IDA) of Singapore INMETRO Mark Institute of Standards of Cambodia (ISC) Instituto Argentino de Normalización y Certificación (IRAM) ISC Mark ISI Mark Israel’s Ministry of Health (IMOH) 113 91 134 27 98 25 53 18 53 69 119 K KC Mark KCC Mark Korea Energy Management Corporation (KEMCO) Korea Food & Drug Administration (KFDA) Korean Communications Commission (KCC) 83, 85 85 87 86 85 G GKRCH15 GOST-R Mark 14, 16 144 Quick Access to Global Markets M Malaysian Communications and Multimedia Commission (MCMC) 89 Medical Device Control Division, Thai Food and Drug Administration (FDA) 110 Medical Device Control Office (MDCO), Department of Health (DOH) 67 Medical Devices Bureau (MDB), Ministry of Health 91 MEDSAFE, Ministry of Health 47 MIC Mark 79 Ministry of Commerce, Industry and Energy (MOCIE) 87 Ministry of Communications (MoC) Israel 118 Ministry of Communications Kuwait 121 Ministry of Economic Development 45 Ministry of Economic Development, Energy Safety 44 Ministry of Economic Development, Radio Spectrum Management (RSM) 46 Ministry of Economy, Trade & Industry (METI) 78 Ministry of Economy, Trade and Industry (METI) 81 Ministry of Energy and Mineral Resources 74 Ministry of Health 55 Ministry of Health (MOH) 51, 115 Ministry of Health, Labour and Welfare (MHLW) 80 Ministry of Industry 74 Ministry of Industry & Information Industry (MIIT) 59, 62 Ministry of Industry and Commerce (MOCI) 125, 120 Ministry of Industry and Trade 116 Ministry of Industry, Mines and Energy (MIME) 53 Ministry of Internal Affairs and Communications (MIC) 79 Ministry of Knowledge Economy (MKE) 83 Ministry of Land, Infrastructure and Transport 81 Ministry of National Infrastructures Ministry of Posts and Telecommunications (MPTC) Ministry of the Environment (MOE) Ministry of Trade and Industry (MINPROMTORG) 120 54 87 15 N National Administration of Drugs, Foodstuffs and Medical Technology (ANMAT), Ministry of Health 20 National Communications Commission (NCC) 104 National Environment Agency (NEA) 107 National Institute of Metrology, Standardization and Industrial Quality (INMETRO) 22, 25 National Regulator for Compulsory Specifications (NRCS) 133, 134 National Resources Canada (NRCan) 29 National Telecommunications Commission (NTC) 94, 108 Nationally Recognized Test Laboratory (NRTL) 34 NCC Certification Mark 104 NOM Certification 30 NSW Fair Trading 39 NYCE30 O Occupational Safety and Health Administration (OSHA) Office of the Telecommunications Authority (OFTA) 34 64, 66 P Philippine Standard (PS) Quality Certification Mark PSE Mark Public Authority for Industry (PAI) 93 78 121 145 Quick Access to Global Markets R Regulatory Compliance Mark T 39, 44 S Safety Mark 97 Saudi Arabian Standards Organization (SASO) 6, 125, 128 Saudi Food & Drug Authority (SFDA) 127 Secretariat of Commerce and Industrial Promotion (SECOFI) 30 Secretariat of Health, Ministry of Health 32 Secretariat of Industry, Commerce and Mining 18, 21 SII Safety Mark 117 SIRIM Label 88, 89 S-Mark18 SNI Mark 74 Standards Council of Canada (SCC) 26 Standards Institution of Israel (SII) 117 State Food and Drug Administration (SFDA) 61 State Radio Regulation Centre (SRRC) 60 Suruhanjaya Tenaga (ST) 88, 92 Telecommunication Engineering Centre (TEC), Department of Telecommunications 72 Telecommunications Regulatory Authority (TRA) 130 Thai Industrial Standards Institute (TISI), Ministry of Industry 107 The Energy Commission See Suruhanjaya Tenaga (ST) The Standards, Productivity and Innovation Board (SPRING Singapore) 97 Therapeutic Goods Administration (TGA) 42 TIS Mark 107 V VCCI Council Vietnam Certification Centre (QUACERT) quality mark 79 112 W Wireless Planning and Coordination (WPC) Wing, Ministry of Communications and IT 71 146 www.tuv-sud.com Asia Pacific TÜV SÜD Asia Pacific 3 Science Park Drive # 04-01, The Franklin Singapore 118223 +65-6427-4700 www.tuv-sud.com Central & Eastern Europe TÜV SÜD Czech s.r.o. Novodvorská 994/138 142 21 Praha 4 Czech Republic +420 239-046-700 www.tuev-sued.de Western Europe TÜV SÜD Product Service Ridlerstraße 65 80339 München Germany +49 (0)89-5008-40 www.tuev-sued.de Asia Pacific Bangladesh TÜV SÜD Bangladesh Level 7 & 8, Update Tower 1 Shajalal Avenue, Sector 6 Uttara Model Town Dhaka 1230 Bangladesh +88 0 2895 8104 www.tuv-sud.com.bd Indonesia TÜV SÜD PSB Indonesia Rukan Grand Puri Niaga Jl. Puri Kencana Blok K-6 No. 2 O Kembangan Selatan Jakarta Barat 11610 Indonesia +62-21-2887-5091/2 www.tuv-sud-psb.co.id Malaysia TÜV SÜD PSB Malaysia Unit 842 & 846, Block A Kelana Centre Point Jalan SS7/19, Kelana Jaya 47301 Petaling Jaya Selangor Darul, Ehsan Malaysia +60-3-7880-1995 www.tuv-sud-psb.com.my China TÜV SÜD China No. 88 Heng Tong Road Shanghai 200070 P.R. China +86-21-6141-0123 www.tuv-sud.cn Japan TÜV SÜD Japan Sumitomo Fudosan Nishi-Shinjuku No. 4 8F, 4-33-4, Shinjuku-ku, 160-0023 Tokyo Japan +81-3-3372-4821 www.tuv-sud.jp Philippines TÜV SÜD PSB Philippines Unit 1808, The Orient Square Bldg. F. Ortigas Jr. Road Ortigas Center, Pasig City Metro Manila 1605 Philippines +632-687-5673 to 75 www.tuv-sud-psb.ph Korea TÜV SÜD Korea “KLI63” Bldg., #60, Yoido-Dong Youngdeungpo-Gu Seoul 150-763 Korea +82-2-3215-1100 www.tuv-sud.kr Singapore TÜV SÜD PSB Singapore 1 Science Park Drive Singapore 118221 Singapore +65-6778-7777 www.tuv-sud-psb.sg Hong Kong TÜV SÜD Hong Kong 3/F, West Wing, Lakeside 2 10 Science Park West Avenue, Shatin Hong Kong +852-2776-1323 www.tuv-sud.hk India TÜV SÜD South Asia TÜV SÜD House Off Saki Vihar Road Saki Naka, Andheri (East) Mumbai – 400072 India +91-22-3082-9797 www.tuv-sud.in Sri Lanka TÜV SÜD Lanka No. 370, Nawala Road Rakagiriya Sri Lanka +94-112-871077 www.tuv-sud.in Contact us at icm@tuev-sued.com Taiwan TÜV SÜD Taiwan 7F., No. 37, Sec. 2 Zhongyang S. Rd. Beitou District Taipei City 11270 Taiwan (R.O.C.) +886-2-2898-6818 www.tuv-sud.tw Thailand TÜV SÜD PSB Thailand 111 Thailand Science Park, Moo 9 Paholyothin Rd. Klong 1, Klong Luang Pathumthani 12120 Thailand +66-2564-8041 www.tuv-sud-psb.co.th Vietnam TÜV SÜD PSB Vietnam 6th Floor, Loyal Building 151 Bis Vo Thi Sau Street Ward 6, District 3 Ho Chi Minh City Vietnam +84-8-3-820-8831 www.tuv-sud-psb.vn Version: January 2011/QA2.0 Americas TÜV SÜD America Inc. 10 Centennial Drive Peabody, MA 01960 USA +1 978-573-2500 www.tuvamerica.com www.tuv-sud.com Americas TÜV SÜD America Inc. 10 Centennial Drive Peabody, MA 01960 USA +1 978-573-2500 www.tuvamerica.com Americas Brazil TÜV SÜD do Brasil Rua Henrique Monteiro n. 90 10.°, 05451-030 Sao Paulo, Brazil +55 11-3021-1117 Asia Pacific TÜV SÜD Asia Pacific 3 Science Park Drive # 04-01, The Franklin Singapore 118223 +65-6427-4700 www.tuv-sud.com Canada TÜV SÜD Canada 180 Brodie Drive, Unit 2 Richmond Hill, Ontario L4B 3K8, Canada +1 519-716-6703 www.tuvcanada.ca Central & Eastern Europe TÜV SÜD Czech s.r.o. Novodvorská 994/138 142 21 Praha 4 Czech Republic +420 239-046-700 www.tuev-sued.de Mexico TÜV SÜD América de México S.A. de C.V. Encino No. 1618 Fracc. Arboledas C.P.31125 Chihuahua, Mexico +5 1-421 4204 www.tuvmex.com.mx USA TÜV SÜD America Inc. 10 Centennial Drive Peabody, MA 01960 USA +1 978-573-2500 www.tuvamerica.com Contact us at icm@tuev-sued.com Version: January 2011/QA2.0 Western Europe TÜV SÜD Product Service Ridlerstraße 65 80339 München Germany +49 (0)89-5008-40 www.tuev-sued.de www.tuv-sud.com Asia Pacific TÜV SÜD Asia Pacific 3 Science Park Drive # 04-01, The Franklin Singapore 118223 +65-6427-4700 www.tuv-sud.com Central & Eastern Europe TÜV SÜD Czech s.r.o. Novodvorská 994/138 142 21 Praha 4 Czech Republic +420 239-046-700 www.tuev-sued.de Western Europe TÜV SÜD Product Service Ridlerstraße 65 80339 München Germany +49 (0)89-5008-40 www.tuev-sued.de Western Europe Austria TÜV SÜD Landesgesellschaft Österreich GmbH Tiwagstr. 7 A-6200 Jenbach Austria +43 5244-63967-16 www.tuev-sued.at Belgium TÜV SÜD BENELUX bvba Betekomsestraat 98 A B-3128 Baal Belgium +32 (0)1646-5127 www.tuev-sued.de France TÜV SÜD France SAS Acticentre - CRT N°2 Bâtiment B - Lot 3 rue des Famards 59818 Lesquin Cedex (Fretin) France +33 3 2044-0740 Germany TÜV SÜD Product Service GmbH Ridlerstraße 65 80339 München Germany +49 (0)89-5008-40 www.tuev-sued.de Italy TÜV Italia S.r.I. edificio 23 Via Carducci 125 20099 Sesto S. Giovanni Italy +39 022-4130-1 www.tuv.it Spain TÜV SÜD Iberia S.L.U. C/ Frederic Mompou, 4 A, 1º 4ª E - 08960 San Just Desvern Barcelona, Spain +34 93490 2220 www.tuev-sued.es Switzerland Swiss TS Technical Services AG Richtistraße 15 8304 Wallisellen Switzerland +41 44 877 62 22 United Kingdom TÜV SÜD (UK) Ltd. Octagon House Concorde Way PO 15 5RL Fareham United Kingdom +44 1489-55-8100 www.tuvps.co.uk Contact us at icm@tuev-sued.com Version: January 2011/QA2.0 Americas TÜV SÜD America Inc. 10 Centennial Drive Peabody, MA 01960 USA +1 978-573-2500 www.tuvamerica.com www.tuv-sud.com Asia Pacific TÜV SÜD Asia Pacific 3 Science Park Drive # 04-01, The Franklin Singapore 118223 +65-6427-4700 www.tuv-sud.com Central & Eastern Europe TÜV SÜD Czech s.r.o. Novodvorská 994/138 142 21 Praha 4 Czech Republic +420 239-046-700 www.tuev-sued.de Western Europe TÜV SÜD Product Service Ridlerstraße 65 80339 München Germany +49 (0)89-5008-40 www.tuev-sued.de Central & Eastern Europe Croatia TÜV SÜD Sava d.o.o. Savska 66 / VIII HR - 10000 Zagreb Croatia +385 1-6130-565 www.tuv-sud.hr Czech Republic TÜV SÜD Czech s.r.o. Novodvorská 994/138 142 21 Praha 4 Czech Republic +420 239-046-700 www.tuev-sued.de Hungary ÉMI-TÜV SÜD Kft. 1043 Budapest, Dugonics u. 11. Levélcím: 1325 Budapest, Pf. 302. Hungary +36 1-210-9570 www.kermi.hu Poland TÜV SÜD Polska Sp. z o.o. Ul. Podwale 17 00-252 Warsaw Poland +48 22-696-4396 www.tuevpolska.pl Romania TÜV SÜD Romania S.r.l. Calea Victoriei 155 RO- 010073 Bucuresti-1 Romania +40 21-330-6600 Russia TÜV SÜD Russland O.O.O. uliza Krasnoarmejskaja 10/2 125167 Moscow Russia +7 495-221-1804 www.tuev-sued.ru Serbia TÜV SÜD Serbia d.o.o. Starine Novaka 3 SRB - 11000 Beograd Serbia +381 11 244 11 11 www.tuv.rs Slovenia TÜV SÜD Sava d.o.o. Likozarjeva ulica 14 SI - 1000 Ljubljana Slovenia +386 1 300-6140 www.tuv-sud.si Turkey TÜVTURK Güney A.S. Büyükdere Cad. No: 71 Nurol Plaza A Blok Kat: 17 -18 Maslak 34398 Istanbul Turkey +90 212 366 99 00 www.tuv-bursa.com.tr Slovakia TÜV SÜD Slovakia s.r.o. Jasikova 6 821 03 Bratislava Slovakia +421 2-48291-234 www.tuvslovakia.sk Contact us at icm@tuev-sued.com Version: January 2011/QA2.0 Americas TÜV SÜD America Inc. 10 Centennial Drive Peabody, MA 01960 USA +1 978-573-2500 www.tuvamerica.com

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