2Conformity Assessment Programs GOVERNMENT AGENCIES INVOLVED:INMETRO (The National Institute of Metrology, Standardization and Industrial Quality)Conformity assessments programs in generalCertification and Energy Efficiency Labelling ProgramANATEL (National Telecommunication Agency)All Telecom products have special requirements in BrazilANVISA (National Health Surveillance Agency )Medical devices in generalIBAMA (Brazilian Institute of Environment and Natural Resources)Noise Level Labelling Program
3Mandatory/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)IBAMA (Noise Level Labelling Program)Brazilian Standards:ABNT/NBR (All kinds of product, most of them are translated from IEC standards)Lab Accreditation (17025 audit):INMETRO
4INMETRO Certification Process Initial ProcessProduct Documents by CustomerTests (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 AnalysisTechnical ReportConformity CertificateMaintenance Process (1 or 2 times / year)Partial tests required for mandatory or voluntary processesFactory Inspection (routine tests are verified)
5INMETRO: Mandatory List - Examples Components:Plugs and Socket-Outlets (ABNT NBR NM and NBR 14136)Switches for fixed installations (NBR NM )Circuit Breakers (NBR IEC and NBR NM 60898)Wires and cables (NBR NM 247, NBR and others)Plug and Socket-Outlets Adapters (NBR 14936)Magnetic Ballasts (NBR 5114 and NBR 5172)Electronic Ballasts (NBR and NBR 14418)House Appliances:Drinking Fountains (NBR and IEC )Water filters (NBR and NBR 15176)(new INMETRO rule for all house appliances after July 2011)
6INMETRO: Mandatory List - Examples IT Equipments:Voltage Stabilizer (NBR 14373)Areas:Eletro-medical devices (ABNT NBR NM series)Electric Equipments for use in Explosive Atmospheres, under inflammable gases and steam conditions (IEC series, IEC and IEC )
7INMETRO Process – New Mandatory Certification INMETRO Decree number 371 from December 29th 2009After July 2011: all house appliances with mandatory certificationMandatory list: IEC X familyMain differencesMaintenance 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.
8INMETRO 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 CharacteristicsCertification 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
9ANATEL – Telecom Products Rules: ANATEL Resolutions:Examples:242 - Certification and homologation rules323 - Product Certification Standard529 - Electric Safety TestsTechnical Requirements: ANATEL specific rules for product classificationBasic Steps:Product classification under ANATEL Requirements => applicable tests and proceduresCertification => product tests and technical analysisHomologation => document verification done by ANATELMaintenance => recurring events based on Product Category
10ANVISA: Medical Products Certification Process:INMETRO => mandatory certification of eletro-medical devicesCertification Bodies => certification processRegistration Process:ANVISA: Health Surveillance Brazilian AgencyRegistration Offices and/or Legal Representers or ImportersBasic Steps:Product classification under applicable Brazilian standardsVerification if standards are under mandatory certificationCertification => product tests and technical analysisRegistration => document verification and ANVISA RequirementsMaintenance => yearly document verification or factory inspection
11ANVISA: Medical Products Main Rules:Directive Resolution (RDC) number 032 from 2007Defines Registration Process as mandatory;Basic procedure for registration process;The certification is required for the registration process;Normative Instruction (IN) number 08 from 2009List of applicable standards under mandatory registration process;The IEC Applicable Medical Devices shall be certified according to INMETRO rules.
12IBAMA: Noise Level Labelling Program Also known as SELO RUIDOMandatory List:Vacuum cleaners;Blenders;Hair Dryers.General CharacteristicsCertification 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.