Things You Should Know About Medical Device Registration in BrazilThis blog is part of a series covering general regulatory requirements and developments in Asia-Pacific and LATAM countries. In this blog, the jurisdictions of attention are Brazil.
General InformationThe Agência Nacional de Vigilância Sanitária (ANVISA) is the National Health Surveillance Agency responsible for registering medical devices and maintaining a registered products database in Brazil. RDC 751/2022, applicable since March 1st, 2023, is the regulation that applies to all medical devices. Used or reconditioned medical devices, custom-made devices, devices for in-vitro diagnostics (IVDs), drugs, cells, tissue, organ or blood from human origin or derivatives, cosmetics, sanitizing or food products for which there is specific regulation apart are out of the scope of this resolution.
Medical devices are classified in Brazil following a risk-based approach comparable with the European Union and the FDA classification systems. ANVISA has 22 rules of classification, which split the devices into Risk I – low risk, Risk II – medium risk, Risk III – high risk, and Risk IV – maximum risk.
Companies without an establishment in Brazil are required to appoint a Brazilian Notification or Registry Holder (BRH), which is responsible for the medical device in the Brazilian territory and holds its commercialization after ANVISA releases it. This legal entity can be either the manufacturer, the importer/distributor, or an independent representative and must be the one presented on the device's labeling. The BRH will coordinate the Brazilian Good Manufacturing Practice (B-GMP) certification, take care of reportable events and recalls, and assist in renewals and modifications of device registrations. ANVISA allows registration holders to give authorization to other companies to import products.
Market AccessBrazil is part of the Medical Device Single Audit Program (MDSAP) and co-founder of the International Medical Device Regulators Forum (IMDRF). However, it requires its own registration process, which shall be performed in electronic format through the ANVISA's Electronic Petitioning System. Some Latin American countries may accept ANVISA approval as part of the process for registering medical devices in their own markets, thereby facilitating the entry of these products.
Medical devices from risk class I/II are submitted to ANVISA using the Notification process ("Notificação"). This process requires that fewer documents are sent to the agency and does not need revalidation. However, those devices still must have the full technical dossier completed before submission, and it is subject to review under audit and possible revocation of the market.
Medical devices from risk class III/IV are submitted to ANVISA using the Registration process ("Registro"). This process requires that the full technical dossier is subject to experts' assessment with rounds of answers and questions.
All documentation can be provided in Portuguese, Spanish, or English. This language flexibility should allow manufacturers to present the same documentation from other markets, such as Canada, the EU, and the USA. However, labeling material and instructions for use must be written in Portuguese.
Additional RequirementsAll manufacturers must comply with the Brazilian Good Manufacturing Practice (B-GMP) requirements as an additional step in the registration process, regardless of the device classification. The manufacturer must declare knowledge and use of the B-GMP for risk class I/ II devices subjected to the Notification route. For risk class III/ IV devices subject to the Registration route, the actual register is conditioned to the publication of the B-GMP certificate, which applies to every factory unit and will request an on-site audit performed by ANVISA. Such a certificate will be valid for two years. After this period, ANVISA could grant a B-GMP recertification based on documentation analysis instead of a re-inspection on site of overseas manufacturers. Brazil is also an MDSAP member, so that this certification can be used.
ANVISA also requires that certain medical devices, such as electro-medical devices subject to IEC 60601, be certified by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO). INMETRO itself does not conduct certification but by accredited Certification Bodies. Testing for electro-medical products performed outside Brazil is usually accepted. Certified products will present an INMETRO mark.
Medical devices and/or their accessories with telecommunications modules in their technical characteristics, such as wireless communication modules, Bluetooth, wifi, a cellular interface, etc., using telecommunication/wireless communication, are also required to be certified by the National Agency for Telecommunications (ANATEL).
Registration ValidityRevalidation is not required for medical devices class I and II. Revalidation must be performed every ten years for higher-risk devices (classes II and IV).
Concluding remarks Brazil is the largest medical device market in Latin America, which is interesting per se. In addition, ANVISA has tried to harmonize the requirements and the requested documentation for registering medical devices in Brazil with other countries, especially the IMDRF, MERCOSUL, and EU members.
How can we help?Qserve is happy to support you in compiling the required documents and registering your devices as needed. Our global registration team will help you register your medical devices in Brazil and other countries. Please
contact us if you need any help.
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Previous blog about Brazil10 Things You Should Know About the New Brazilian Regulation of Medical Devices | ANVISA RDC 751/2022, written by Patrícia da Silva Perez, March 2023.