Obtaining the Brazil INMETRO certification for your electrical medical product



For commercialization of products in the Brazilian market, the national health surveillance agency ANVISA requires certification as part of the requirements prior to granting registration. The marking obtained by this process is given by CGCRE - General Coordination for Accreditation of INMETRO (the National Institute of Metrology, Standardization and Industrial Quality) via accredited bodies. The INMETRO seal is mandatory and guarantees the quality, safety and efficacy of marketed products in the country. It is important to know that the reasoning for the certification process is intended primarily to inform and protect consumers, particularly with regard to health, safety and the environment. In addition, the product certification seeks to promote fair competition between the manufacturers and encourage continuous quality improvements in products. Globally, the certification provides adequate control with regards to international trade, while at the same time strengthening Brazil's internal market. The ANVISA Definition of Medical Devices ANVISA defines medical devices as appliances, materials or accessories whose use or application is related to safeguarding individual or collective health, personal hygiene or cleanliness of surroundings; for diagnostic and analytical purposes; including cosmetic and perfume, as well as dietetic, optical, medical acoustic, odontology, and veterinary products. Specifically: - Diagnostic equipment - Therapy equipment - Medical-hospital support equipment - Disposable materials and devices - Implantable materials and devices (certification process not mandatory) - Medical-hospital support materials and devices - In-vitro diagnostic products (certification process not mandatory) - Beauty and aesthetics devices Regulatory compliance Medical devices intended for sale in Brazil must be prior approved by ANVISA and accredited by CGCRE - General Coordination for Accreditation of INMETRO via an approved certification body. ANVISA has developed a set of essential requirements for medical device compliance, similar to those in the EU, which gives two routes to ANVISA approval: i) Cadastre and ii) Registration. Two routes to approval i) Cadastre is for lower risk devices, and the simplest and quickest route to approval. ii) Registration is a more complex process Cadastre and Registration require similar documentation during the approval process. The following steps are required to be followed: - Step 1 Conduct an ANVISA Good Manufacturing Practice (GMP) audit. The GMP audit is performed directly by ANVISA and must be done before the registration submission, because the GMP certificate issued is a pre-requirement for the registration submission for products class III, IV and some products class I and II (according to the Brazilian regulations). It is necessary to classify the product for registration first to determine if GMP will be required or not. - Step 2 Electro-medical devices covered by any standard included in the Normative Instruction No.3 issued by ANVISA must be certified by a CGCRE of INMETRO accredited 'Organization of Certification of Product' and display the INMETRO mark. This process includes: - Initial factory inspection against ISO 13485 plus additional requirements of ORD 350 Product testing of all INMETRO marked goods conducted by IEC accredited laboratories (accredited by a member of ILAC, IAAC or EA). - Product test reports must be no more than two years old for initial certification and repeated at renewal, if the test reports are older than five years. - Annual surveillance inspections based on ISO 13485 and ORD 350 requirements to ensure standards continue to be met. Please Note: Brazil uses international standards to guide their rules; however, these naturally undergo an adaptation to local requirements. Regarding the transition to the third edition of the series of standards IEC60601-x there is a large commitment from all sectors involved. In 2013 both second edition and third edition test reports of basic electrical medical equipment standard family IEC 60601-X can be applied. It is expected that from 2014 the third edition of the series of standards will be mandatory. - Step 3 Technical documentation is submitted to ANVISA. - Step 4 Approval achieved. Further Requirements Additional to the Approval Process - Import controls Customs agents check medical devices transported to Brazil against the ANVISA database. This is to ensure all medical devices comply with the registration requirements before they are allowed entry into the country. - Local representation To sell your products in Brazil you must meet the ANVISA approval requirements and have a local representative within Brazil who can act on your behalf in all product-related matters. SGS Consumer Testing Services