Brazilian Approvals
Electrical Equipments
Conformity Assessment Programs

GOVERNMENT AGENCIES INVOLVED:

INMETRO (The National Institute of Metrology, Standardization and
Industrial Quality)
 www.inmetro.gov.br
 Conformity assessments programs in general
 Certification and Energy Efficiency Labelling Program

ANATEL (National Telecommunication Agency)

ANVISA (National Health Surveillance Agency )

IBAMA (Brazilian Institute of Environment and Natural Resources)
 www.anatel.gov.br
 All Telecom products have special requirements in Brazil
 http://www.anvisa.gov.br/eng/index.htm
 Medical devices in general
 http://www.ibama.gov.br/
 Noise Level Labelling Program
Mandatory/Voluntary Certifications: Brazilian
Certification Structure

Brazilian Certification Process:
 INMETRO (All kinds of products, except Telecom products)
 ANATEL (Telecommunication products)
 Brazilian Registration Process (usually it is done by the local
representative):
 ANVISA (Medical devices)
 ANATEL (Telecommunication products)
 IBAMA (Noise Level Labelling Program)

Brazilian Standards:
 ABNT/NBR (All kinds of product, most of them are translated from
IEC standards)
 ANATEL (Telecommunication products)

Lab Accreditation (17025 audit):
 INMETRO
INMETRO Certification Process
 Initial Process
 Product Documents by Customer
 Tests (Test reports can be accepted by accredited laboratories
– accreditation body is member of ILAC)
 Factory Inspection (items from ISO 9001:2008)
 Tests Reports and Documents Analysis
 Technical Report
 Conformity Certificate
 Maintenance Process (1 or 2 times / year)
 Partial tests required for mandatory or voluntary processes
 Factory Inspection (routine tests are verified)
INMETRO: Mandatory List - Examples
 Components:
 Plugs and Socket-Outlets (ABNT NBR NM 60884-1 and NBR 14136)
 Switches for fixed installations (NBR NM 60669-1)
 Circuit Breakers (NBR IEC 60947-02 and NBR NM 60898)
 Wires and cables (NBR NM 247, NBR 13249 and others)
 Plug and Socket-Outlets Adapters (NBR 14936)
 Magnetic Ballasts (NBR 5114 and NBR 5172)
 Electronic Ballasts (NBR 14417 and NBR 14418)
 House Appliances:
 Drinking Fountains (NBR 335-1 and IEC 60730-2-8)
 Water filters (NBR 14908 and NBR 15176)
(new INMETRO rule for all house appliances after July 2011)
INMETRO: Mandatory List - Examples
 IT Equipments:
 Voltage Stabilizer (NBR 14373)
 Areas:
 Eletro-medical devices (ABNT NBR NM 60601 series)
 Electric Equipments for use in Explosive Atmospheres, under
inflammable gases and steam conditions (IEC 60079 series, IEC 60529
and IEC 60034-5)
INMETRO Process – New Mandatory Certification
 INMETRO Decree number 371 from December 29th 2009
 After July 2011: all house appliances with mandatory certification
 Mandatory list: IEC 60335-2-X family
 Main differences
 Maintenance process performed every 1 year;
 Samples for maintenance tests collected in the market or
Brazilian importer warehouse;
 Customer complaint service to be checked in the Brazilian
Distributor or Importer.
INMETRO Energy Efficiency Labelling Program
 ENERGY EFFICIENCY LABELLING PROGRAM (PROCEL)
 Partial Mandatory List:
 Air conditioners;
 Refrigerators;
 Gas Stoves;
 Washing Machines;
 Ceiling Fans;
 LCD TV’s.
 General Characteristics
 Certification Bodies not involved;
 Applied directly to INMETRO by the Brazilian Legal
Representer or Importer;
 Tests performed in Brazilian accredited laboratories or
manufacturer laboratories after INMETRO evaluation
ANATEL – Telecom Products

Rules: ANATEL Resolutions:
 Examples:
 242 - Certification and homologation rules
 323 - Product Certification Standard
 529 - Electric Safety Tests

Technical Requirements: ANATEL specific rules for product classification

Basic Steps:
1. Product classification under ANATEL Requirements => applicable
tests and procedures
2. Certification => product tests and technical analysis
3. Homologation => document verification done by ANATEL
4. Maintenance => recurring events based on Product Category
ANVISA: Medical Products

Certification Process:
 INMETRO => mandatory certification of eletro-medical devices
 Certification Bodies => certification process

Registration Process:
 ANVISA: Health Surveillance Brazilian Agency
 Registration Offices and/or Legal Representers or Importers

Basic Steps:
1. Product classification under applicable Brazilian standards
2. Verification if standards are under mandatory certification
3. Certification => product tests and technical analysis
4. Registration => document verification and ANVISA Requirements
5. Maintenance => yearly document verification or factory inspection
ANVISA: Medical Products
 Main Rules:
 Directive Resolution (RDC) number 032 from 2007
 Defines Registration Process as mandatory;
 Basic procedure for registration process;
 The certification is required for the registration process;
 Normative Instruction (IN) number 08 from 2009
 List of applicable standards under mandatory registration
process;
 The IEC 60601-1 Applicable Medical Devices shall be
certified according to INMETRO rules.
IBAMA: Noise Level Labelling Program
 Also known as SELO RUIDO
 Mandatory List:
 Vacuum cleaners;
 Blenders;
 Hair Dryers.
 General Characteristics
 Certification Bodies partially involved;
 Tests: only Brazilian accredited laboratories;
 Samples: collected in Brazilian local distributor;
 Noise Level Declaration: issued by Certification Bodies;
 Declaration applied directly to IBAMA Agency by the
Brazilian Legal Representer or Importer to get authorization
to use the Selo Ruido Label.