Brazilian ApprovalsBrazilian Approvals

Electrical EquipmentsElectrical Equipments

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)

www.anatel.gov.br

All Telecom products have special requirements in Brazil

ANVISA (National Health Surveillance Agency )

http://www.anvisa.gov.br/eng/index.htm

Medical devices in general

IBAMA (Brazilian Institute of Environment and Natural Resources)

http://www.ibama.gov.br/

Noise Level Labelling Program

Conformity Assessment ProgramsConformity Assessment Programs

Mandatory/Voluntary Certifications:Mandatory/Voluntary Certifications: Brazilian Brazilian Certification StructureCertification 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 ProcessINMETRO 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 - ExamplesINMETRO: 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 - ExamplesINMETRO: 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 CertificationINMETRO 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 ProgramINMETRO 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

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 procedures2. Certification => product tests and technical analysis3. Homologation => document verification done by ANATEL4. Maintenance => recurring events based on Product Category

ANATEL – Telecom ProductsANATEL – Telecom 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 standards2. Verification if standards are under mandatory certification3. Certification => product tests and technical analysis4. Registration => document verification and ANVISA Requirements5. Maintenance => yearly document verification or factory inspection

ANVISA: Medical ProductsANVISA: 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.

ANVISA: Medical ProductsANVISA: Medical Products

IBAMA: Noise Level Labelling ProgramIBAMA: 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.