Global Regulatory Changes Prepared for TCBC Meeting – 09-Apr-14 Scope of Presentation Introduction to PCS Global Regulatory Changes – Overview Country Specific Focus Eurasian Customs Union Indonesia India BIS Ukraine Summary on other Regulatory Changes 9-Apr-15 Product Compliance Specialists Confidential 2 Introduction to PCS Dynamic UK based Company established in 2004 Specialists in managing certification of radio, telecommunications and ITE products 12,000 Approvals obtained in 160 countries Multi-lingual team with 9 key languages spoken We specialize in international projects and frequently manage projects for 50+ countries simultaneously International blue chip customer base 9-Apr-15 Product Compliance Specialists Confidential 3 Global Regulatory Changes - Overview Significant Regulatory Changes in the following countries Argentina Bolivia Malaysia Pakistan 9-Apr-15 Product Compliance Specialists Confidential 4 Regulatory Changes Argentina Sep 2013 - New standard affecting 2.4GHz and 5GHz WLAN released Came into effect on 4th November 2013 All 2.4GHz and 5GHz devices tested under previous standard must be retested at the time of renewal 5600 - 5650MHz portion of the 5GHz Band 3 no longer permitted Bluetooth 2.1 exempt from retesting requirement 9-Apr-15 Product Compliance Specialists Confidential 5 Regulatory Changes Bolivia Type Approval requirements enforced – June 2013 Previously FCC Approval was sufficient Temporary Approvals issued during transition period, invalidated – full Approval now required Local applicant required Paperwork only process Lead-time ~ 5 – 6 weeks Validity 5 years 9-Apr-15 Product Compliance Specialists Confidential 6 Regulatory Changes Malaysia Add-Host Approval Scheme for Modules Abolished – Mar 2014 No longer possible to add host models to Approved modules via paperwork only process Each host now requires Approval in full, inclusive of local testing / sample inspection. Products Approved prior to change in regulations – not affected. 9-Apr-15 Product Compliance Specialists Confidential 7 Regulatory Changes Pakistan Approval requirements for Mobile Phones introduced. Jan 2014 – Pakistan Telecommunication Authority (PTA) introduced Type Approval requirements for cellular mobile devices New rules also apply to WWAN equipped tablets, and WWAN devices which are data only 9-Apr-15 Product Compliance Specialists Confidential 8 EA Customs Union (EAC) Approval Scheme Customs Union Agenda Introduction Scope and Limitations Differences to GOST, Advantages and Disadvantages Overview of Approval Schemes Certification Declaration Exemption Letter Serial and Batch Approval Product Categorization Labelling Requirements 9-Apr-15 Product Compliance Specialists Confidential 10 Customs Union Introduction Overview Harmonization of regulations for EMC (Electromagnetic Compatibility) and LVE (Low-voltage equipment) across Customs Union member states of Russia, Belarus and Kazakhstan Implemented Feb 2013 as replacement to the independent national GOST EMC / Safety Approval schemes previously enforced in these countries EA Customs Union (EAC) Approval is a singular harmonized Approval Certificate for EMC and / or Safety that covers all member states in the union 9-Apr-15 Product Compliance Specialists Confidential 11 Customs Union Introduction Scope and Limitations Customs Union Approval does not cover RF or Telecom For RF or Telecom devices, separate national Approval to cover RF / Telecom function must still be obtained in Russia and Belarus Kazakhstan has no separate RF scheme so Customs Union Approval alone is sufficient. 9-Apr-15 Product Compliance Specialists Confidential 12 Customs Union Introduction Key Differences From GOST Changes GOST Scheme Customs Union Scheme Applicant Foreign Manufacturer or Local Company Local Company Route to Approval Single route via accredited lab Multiple routes and options – CoC, DoC, Exemption Letter Local Testing Requirement weakly enforced Requirement much more rigidly enforced Factory Inspection No requirements / requirement weakly enforced Requirement much more rigidly enforced Certificate Validity Maximum up to 3 Years Maximum up to 5 Years Voluntary Approval Voluntary Approval Possible No Voluntary Approvals Possible 9-Apr-15 Product Compliance Specialists Confidential 13 Customs Union Introduction Advantages and Disadvantages Advantages Single EMC/ Safety Approval Certificate covering all customs union member states Options for Longer Approval Validity Flexibility to apply for Approval in any of the member states Disadvantages Increased complexity – multiple routes and schemes to Approval Stricter requirements – introduces local test and factory inspection requirements. Stricter supervision and monitoring of Certification Bodies 9-Apr-15 Product Compliance Specialists Confidential 14 Customs Union Introduction Transition from GOST Two Year Transition Period Allowed Existing GOST Certificates remain valid until stated expiry date or 15th March 2015 (whichever comes first) As of 15th March 2015, all GOST Certificates in circulation will cease to be valid and must be replaced with a Customs Union Approval 9-Apr-15 Product Compliance Specialists Confidential 15 Customs Union Approval Schemes Three Approval Schemes Certification (Certificate of Conformity) Declaration (Declaration of Conformity) Exemption Letter Certification and Declaration scheme divided in to sub schemes Serial Approval Batch Approval 9-Apr-15 Product Compliance Specialists Confidential 16 Customs Union Approval Schemes Approval Scheme Certification, Declaration or Exemption Letter Determined by product type, function and HS code Approval Scope Batch or Serial Applicant at liberty to select option that best suits their needs and requirements 9-Apr-15 Product Compliance Specialists Confidential 17 Customs Union Approval Schemes Certification Scheme Third Party Certification – Certification Body takes responsibility for compliance Required for devices ‘in scope’ of Customs Union Technical Regulations on EMC and LVE Local Testing Required Physical Factory Audit / Inspection Required Family Approval Possible Local Approval Holder Required Lead Time ~ 12 weeks (FI ~ 12 weeks) Certificate Validity 1 - 5 Years 9-Apr-15 Product Compliance Specialists Confidential 18 Customs Union Approval Schemes Declaration Scheme Applicant takes responsibility for compliance Required for devices ‘out of scope’ of Customs Union Technical Regulations on EMC and LVE Local Testing Required Local Approval Holder Required Family Approval Possible Lead Time ~ 4 Weeks Certificate Validity 1 - 5 Years 9-Apr-15 Product Compliance Specialists Confidential 19 Customs Union Approval Schemes Exemption Letter Required for spare parts which are intended to be imported and sold in Customs Union Region as part of already Approved Host Device. Foreign Manufacturer can hold Approval 9-Apr-15 Product Compliance Specialists Confidential 20 Customs Union Approval Schemes Serial and Batch Approval Serial Approval – For Serial Production – valid for import of unlimited quantity of stated product(s) during lifetime of Approval Batch Approval – For Single Import Consignment Only. Max units unstipulated. Manufacturers expected to apply reasonable judgement. 9-Apr-15 Product Compliance Specialists Confidential 21 Customs Union Product Categorization Categorization ‘In Scope’ and ‘Out of Scope’ – Determines which Approval scheme applies Products ‘In Scope’ of Customs Union EMC and LVE Regulations are subject to Certification. Products ‘Out of Scope’ of EMC and LVE Regulations subject to Declaration Rules can be open to interpretation. Lots of scope for variation and differences of opinion between Customs Union Certification Bodies 9-Apr-15 Product Compliance Specialists Confidential 22 Customs Union Product Categorization Key Factors Determining Product Classification HS Code (Harmonised System Code) Model Name Power Supply and charging mechanism – i.e mains A/C, DC Battery Only Input Voltage Rating Intended Use – Industrial or Consumer HS Code is the chief determinant factor, however is rarely used in isolation alone. One or more of the above may also need to be considered 9-Apr-15 Product Compliance Specialists Confidential 23 Customs Union Product Categorization Getting correct classification is crucial Incorrect classification can lead to: Problems at import stage Severe penalties to manufacturer, local holder and Customs Union CB including: 9-Apr-15 Financial Penalties Confiscation of products Loss of accreditation status Imprisonment Product Compliance Specialists Confidential 24 Customs Union Labelling Customs Union Label Artwork 9-Apr-15 Product Compliance Specialists Confidential 25 Customs Union Labelling Labelling Rules Label should be placed on the product itself, the packaging and the user manual If labelling product not feasible due to size restrictions label may be placed on packaging and user guide only Label must be clear and visible to the naked eye Minimum character height is 5mm 9-Apr-15 Product Compliance Specialists Confidential 26 Indonesia Regulatory Changes Indonesia Agenda General Regulatory Overview Focus on Regulatory Changes Rules for Modular Approval Approval of Dual Band Access Points Other Planned Changes Changes to Type A / Type B Approval New Application Prioritisation System 9-Apr-15 Product Compliance Specialists Confidential 28 Indonesia Regulatory Overview Process and Requirements relatively stable at current Potential for frequent regulatory changes of both minor and major impact Often implementation of changes can be disjointed and problematic due to lack of cohesion between Indonesian Government, Authority, Lab and Customs Several notable and significant changes introduced in 2013 9-Apr-15 Product Compliance Specialists Confidential 29 Indonesia Rules for Modular Approval Multiple changes introduced during 2013 eroding strategic advantage previously conferred through Modular Approvals Modular Approval now only advantageous if the module is imported in to Indonesia in it’s stand-alone state, not integrated in to any host 9-Apr-15 Product Compliance Specialists Confidential 30 Indonesia Rules for Modular Approval Under new regulations - if module is imported in to Indonesia installed inside a host then host Approval must be obtained again in full from scratch Local testing on host must be repeated – not possible to leverage any modular level results. Local importers no longer able to apply for Type B Host Approval, leveraging from Type A Modular Approval 9-Apr-15 Product Compliance Specialists Confidential 31 Indonesia Dual Band Access Points Previously WLAN Access Points could only be Approved for single band use – either 2.4GHz or 5GHz only New Regulations from Jan 2013 – WLAN Access Points may now be Approved for Dual Band Use Indonesia Frequency Plan - Unchanged 2.4GHz – Channels 1 – 13 5GHz – Band 4 Only – Channels 149 – 161 9-Apr-15 Product Compliance Specialists Confidential 32 Indonesia Dual Band Access Points Approval Process for Dual Band Operation is the same as for Single Band Operation Two Accredited Laboratories Authority Lab Accredited Lab Sample Requirements - Strict Samples must be locked to Indonesian bands / channels only 9-Apr-15 Product Compliance Specialists Confidential 33 Indonesia Proposed Changes Numerous proposed changes planned for Indonesia Regulatory process Proposed changes currently still under development and in consultation stage No commitments at current time regarding extent or timeframe of implementation 9-Apr-15 Product Compliance Specialists Confidential 34 Indonesia Proposed Changes Type A and Type B Approval format to be abolished and replaced with new system Type A – Approval issued to manufacturer Type B – Approval issued to importer (Required to Import Goods) Most common approach at current – manufacturer obtains Type A Approval. Importer then obtains Type B Approval via paperwork only approach, leveraging local testing from manufacturers Approval 9-Apr-15 Product Compliance Specialists Confidential 35 Indonesia Proposed Changes Cont. Price structured – applicant selected prioritization system for processing of Type Approval applications Standard Expedite VIP New requirements for assessment of EMC, Safety and Human Exposure For WWAN products – requirement for IMEI letter from authorised body 9-Apr-15 Product Compliance Specialists Confidential 36 India BIS Safety Approval Scheme India BIS Agenda Introduction Background to India Approval Schemes Overview of new BIS Approval scheme What and when Products requiring mandatory BIS Approval Organisations involved in scheme Procedure Overview Registration and product testing Moving forward Labelling Requirements 9-Apr-15 Product Compliance Specialists Confidential 38 India Approvals Overview Up until 2013 there have always been 2 Approval schemes in place in India specifically for this industry: WPC (Ministry of Communications and IT Department of Telecommunications) covering Radio Approvals TEC (Telecommunication Engineering Centre) covering Telecom Approvals 9-Apr-15 Product Compliance Specialists Confidential 39 India BIS – What and when In September 2012, the Electronics and Information Technology Goods (Requirements for Compulsory Registration) Order was introduced, and enforced in March 2013. The Order requires that certain products imported to, manufactured in, stored, distributed or sold in India must conform to the Indian (safety) standards specified in the schedule. These products must then be registered as compliant with the Bureau of Indian Standards (BIS) Technical standards in interest of public health and safety Global quality standards for domestic manufacturers 9-Apr-15 Product Compliance Specialists Confidential 40 Products requiring mandatory BIS 1. Electronic Games (Video) 2. Laptop / Notebook/ Tablets 3. Plasma / LCD / LED Televisions of screen size 32’’ and above 4.Optical Disc Players with built in amplifiers of input power 200W and above 5. Microwave Ovens 6. Visual Displays Units, Videos Monitors of screen size 32’’ and above 7. Printers and Plotters 8. Scanners 9-Apr-15 Product Compliance Specialists Confidential 41 Products requiring mandatory BIS 9. Wireless Keyboards 10. Telephone Answering Machines (excluding EPABX, PABX, Fax machines or VoIP devices) 11. Amplifiers with input power 2000W and above 12. Electronic Musical Systems with input power 200W and above 13. Electronic Clocks with Mains Power 14. Set Top Box 15. Automatic Data Processing Machine 9-Apr-15 Product Compliance Specialists Confidential 42 Testing standards Product Indian Standard Title 1. Electronic Goods IS 616:2010 Audio, Video and Similar Electronic Apparatus - Safety Requirements (IEC 60065:2005) 2. Laptop/Notebooks/Tablets IS 13252:2010 (ISO/IEC 609501:2005) 3. Plasma/LCD/LED Televisions of screen size 32" and above 4. Optical Disc Players with built in amplifiers of input power 2000W and above 9-Apr-15 Information Technology Equipment - Safety - General Requirements IS 616:2010 (IEC 60065:2005) IS 616:2010 (IEC 60065:2005) Product Compliance Specialists Confidential Audio, Video and Similar Electronic Apparatus - Safety Requirements Audio, Video and Similar Electronic Apparatus - Safety Requirements 43 Testing standards Product Indian Standard Title 5. Microwave Ovens IS 302-2-25:1994 Safety of household and similar electrical appliances: Part 2 Particular requirements: Section 25 Microwave ovens (IEC-60335-225:2010) 6. Visual Display Units, Video Monitors of screen size 32" and above IS 13252:2010 (ISO/IEC 609501:2005) 7. Printers, Plotters IS 13252:2003 (ISO/IEC 609501:2005) 8. Scanners IS 13252:2010 (ISO/IEC 609501:2005) 9-Apr-15 Product Compliance Specialists Confidential Information Technology Equipment - Safety - General Requirements Information Technology Equipment - Safety - General Requirements Information Technology Equipment - Safety - General Requirements 44 Testing standards Product Indian Standard Title 9. Wireless Keyboards IS 13252:2010 Information Technology Equipment - Safety - General Requirements (ISO/IEC 609501:2005) 10. Telephone Answering Machines 11. Amplifiers with input power 2000W and above 12. Electronic Musical Systems with input 2000W and above 9-Apr-15 IS 13252:2010 (ISO/IEC 609501:2005) IS 616:2010 (IEC 60065:2005) IS 616:2010 (IEC 60065:2005) Product Compliance Specialists Confidential Information Technology Equipment - Safety - General Requirements Audio, Video and Similar Electronic Apparatus - Safety Requirements Audio, Video and Similar Electronic Apparatus - Safety Requirements 45 Testing standards Product Indian Standard Title 13. Electronic Clocks with Mains Powers IS 302-2-25:1994 Safety of household and similar electrical appliances: Part 2 Particular requirements: Section 25 Microwave ovens 14. Set top box IS 13252:2010 (IEC-60335-225:2010) (ISO/IEC 609501:2005) 15. Automatic Data Processing Machine IS 13252:2010 (ISO/IEC 609501:2005) Audio, Video and Similar Electronic Apparatus - Safety Requirements Information Technology Equipment - Safety - General Requirements CB Test reports therefore play a pivotal role in the BIS Safety Scheme 9-Apr-15 Product Compliance Specialists Confidential 46 Who is involved Deity – Department of Electronic and Information Technology Ministry of Communications & Information Technology, Government of India BIS – Bureau of Indian Standards Deity introduced and oversee the scheme, they update the mandatory list. Manufacturers also must register with Deity. BIS write the Indian standards and responsible for Approval process. No more extensions. 9-Apr-15 Product Compliance Specialists Confidential 47 Process Outline Manufacturer Registration Local Testing (1 functional sample) Product Registration (Type Approval) 9-Apr-15 Product Compliance Specialists Confidential 48 Procedure Overview Manufacturer and Product Registration Both Deity and BIS involved Prior to product registration, each physical manufacturer (final assembly factory) needs to register with Deity Manufacturer registration and product local testing can proceed simultaneously Tests can only be conducted at BIS approved labs in India (per manufacturer) BIS allow for Approval of family/type on one certificate – all models must still be tested. 9-Apr-15 Product Compliance Specialists Confidential 49 Manufacturer Registration Pre-requisites 1. Full name and address of physical manufacturer (as per safety report) 2. Business registration license (or other official government issued document) 3. Contact details of the appointed member of factory manufacturer responsible for BIS registration 4. English translation of above is essential 5. Local nominee required 6. Online process, 3-4 days. 9-Apr-15 Product Compliance Specialists Confidential 50 Accredited labs 1. Electronic Regional Test Laboratory (North) 2. Electronic Regional Test Laboratory (East) 3. Electronics Regional Test Laboratory (West) 4. Electronics Test & Development Centre (Bangalore) 5. UL India Pvt Ltd. Bangalore 6. UL India Pvt Ltd. Manesar (Haryana) 7. TUV Rheinland (India) Pvt. Ltd. (Bangalore) 8. Intertek India Pvt. Ltd. New Delhi 9. Conformity Testing Labs Pvt. Ltd. New Delhi 10. Bharat Test House Pvt. Ltd. Sonepat (Haryana) 11. HI Physix laboratory India Pvt. Ltd. Ranjangaon (Pune) 9-Apr-15 Product Compliance Specialists Confidential 51 Test Report requirements – CB Test reports and critical components CB Test Reports & technical documentation must be submitted ahead of local testing All critical components must be declared and have evidence of conformity to IEC standards Conformity of Critical Components to standards harmonised with IEC will also be accepted. Where IEC standards are not available, test reports issued in compliance with other international & national standards are accepted. “Various” cannot be listed on the Safety report. All sources of manufacturers, models and brands of a component must be identified and verified (with supporting evidence of conformity) 9-Apr-15 Product Compliance Specialists Confidential 52 Product Registration Overview Immediately after local testing is completed and reports issued, products can then register with BIS 4 week process in total. Application submitted electronically and then in hard copy – at times over 100 pages of documents are submitted. Certificate issued with 2 year validity 9-Apr-15 Product Compliance Specialists Confidential 53 Summary: CB test reports still play an essential role and must be submitted to the lab ahead of test start Test reports will be issued by accredited lab for review at BIS Physical manufacturers must be registered before products can be Approved Once reports are issued, applicants can then file for product Approval/registration Certificates are issued for each physical manufacturer Approvals are valid for 2 years – full renewal process is yet to be confirmed 9-Apr-15 Product Compliance Specialists Confidential 54 Procedure Overview – moving forward Approve multiple products of the same type/family simultaneously. Testing time is approx. 2 months Allow 2-3 months from project start to completion Review time is approx. 1 month Local Representation is important 9-Apr-15 Product Compliance Specialists Confidential 55 Labelling requirements “Self Declaration - Conforming to IS xxxxxx, Rxxxxxxxx” IS xxx = standard R = registration number On the product and its packaging 9-Apr-15 Product Compliance Specialists Confidential 56 Ukraine Approval Scheme Ukraine Agenda Introduction Background to Ukraine Approval Schemes Overview on current requirements What and when Organisations involved in scheme Procedure Overview Certification Declaration Moving forward Labelling Requirements 9-Apr-15 Product Compliance Specialists Confidential 58 Ukraine Approvals Background Beginning of 2011 - EMC standards and regulations were released mandating requirement for Declaration on EMC standards in addition to Certification (CoC). Beginning of 2012 - Safety standards and regulations were released mandating requirement for Declaration on Safety in addition to the CoC and EMC Declaration (if applicable) 9-Apr-15 Product Compliance Specialists Confidential 59 Ukraine Approvals Background Beginning of 2013 - RF / Telecom standards and regulations were released to mandate that all RF and Telecom devices would require an R&TTE Declaration, in addition to any applicable EMC and Safety Declaration. End of 2013 – advised that Ukraine Certification (CoC) for RF/Telecom would be abolished. Declarations would remain. 9-Apr-15 Product Compliance Specialists Confidential 60 What and when Changes Before At present Legacy Type Approval (RF / Telecom Certification) Mandatory Failure to sign European Association Agreement in Nov. 2013 - still legally in place, however CAB opinion remains divided Agreement in process for signature, however. Route to Approval Via bi-monthly Commissions Meeting at Authority for Certification CABs now issuing Approvals directly for majority of products Commissions Meeting now only takes place once a month and is for Access Point Declarations & Telecom Certifications only 9-Apr-15 Product Compliance Specialists Confidential 61 What and when Changes Before At present Local Testing Enforced CABs will follow paperwork only process while political unrest continues and customs issues encountered Certification Validity 1 year No expiry for devices such as Short Range Devices, Access Points and Cellular devices. Other products falling under Telecom Law will still have a validity of 1 year Annual Technical Inspection 9-Apr-15 N/A Under discussion for all Certificates with no expiry. Nothing yet in place. Product Compliance Specialists Confidential 62 Who is involved National Commission for the State Regulation of Communications and Information (Authority) Mandate requirements for Certification and Declaration State Service of Special Communication and Information Protection of Ukraine (Authority) Commissions Meetings and Technical Standards Conformity Assessment Bodies (CABs) Local testing Issuance of Certification and Declaration 9-Apr-15 Product Compliance Specialists Confidential 63 Procedure Overview Certification At present, Certification is still legally required for all RF and Telecom devices Still 2 routes to Approval: Product Consignment Certification Serial Production by Test Result Local testing still required* Manufacturer can still hold Approval * At present, varies by CAB 9-Apr-15 Product Compliance Specialists Confidential 64 Procedure Overview Declaration (DoC) EMC - most host devices Safety – anything mains connected R&TTE – all RF and Telecom Self Declared or via CAB 9-Apr-15 Product Compliance Specialists Confidential 65 Outline – Declarations Local testing required – 2 samples required* Local holder required *Manufacturer EU test reports can be leveraged to avoid testing for EMC & Safety Declarations. If R&TTE DoC process runs in parallel to CoC, testing does not need to be repeated. A single DoC listing EMC and/or Safety and/or RF standards can be obtained. No expiry – local holder must maintain DoC for 10 years Products which have obtained R&TTE DoC must also be registered in the national Electronic Device Register of Ukraine – mandatory for import 9-Apr-15 Product Compliance Specialists Confidential 66 Procedure Overview – moving forward Political unrest continues European association Agreement has been partially signed and will be fully signed at some point after Ukraine elections in May 2014 While CAB opinions remain divided, officially legacy Type Approval is still mandatory Local testing requirement temporarily removed due to shipping issues 9-Apr-15 Product Compliance Specialists Confidential 67 Labelling requirements Mandatory for all Products with Declaration(s) If processed via a CAB, CAB number should feature below logo Voluntary only for Certification CAB number should feature below logo Product and/or its packaging, operation and accompanying documents or smallest consumer packaging 9-Apr-15 Product Compliance Specialists Confidential 68 Regulatory Updates Country 9-Apr-15 Change Belarus Early 2014 - Compulsory certification requirement for all radio and telecommunication removed. Declaration now sufficient Removes the need for physical Factory Inspection, but local testing still required. Vietnam New technical standards introduced affecting all RF devices. Additional EMC testing required to ensure its Compliance with QCVN18, full effects being investigated at present. Product Compliance Specialists Confidential 69 Regulatory Updates Country Change Gambia Changes to Type Approval guidelines introduced in July 2013. Certificates issued before 30th October 2013 will automatically expire on 31st December 2015. Renewal is then required. Ghana New Type Approval guidelines implemented in January 2014. Now mandatory to submit samples for local testing. Peru Portions of 902-928MHz band opened up again in 2013 915-928MHz and 916-928MHz have now been assigned as unlicensed bands Yemen 9-Apr-15 Type Approval procedures and requirements introduced at the end of 2013 Type Approval now mandatory. Product Compliance Specialists Confidential 70 Thank you Dave@productcompliancespecialists.com Kathryn@productcompliancespecialists.com Tel: +44 1844 273277 Fax: +44 1844 273278 www.productcompliancespecialists.com 9-Apr-15 Product Compliance Specialists Confidential 71