Representation for foreign manufacturers
Brazilian Registration Notification or Registry Holder (BRH)
Companies without an establishment in Brazil must appoint a Brazilian Registration Holder (BRH) responsible for the medical device in the Brazilian territory that holds its commercialization after being released by ANVISA. This legal entity is called Requester before device clearance, can be either the manufacturer, the importer, or another representative, and must be the one listed on the labelling. 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. Foreign manufacturers are required to appoint a local BRH to ensure compliance, approval of ANVISA, and supply of their product on the Brazilian market.
ANVISA allows registration holders to give authorization to other companies to import products. Therefore, having an independent representative can benefit manufacturers, as they can avoid conflicts of interest and change or add distributors as needed.
Additional Regulatory Requirements
Brazilian Good Manufacturing Practices (B-GMP) certification
All 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. B-GMP is related to the quality control of the devices and not solely to the technical device requirements itself. The manufacturer must declare knowledge and use of the B-GMP for risk class I/ II devices subjected to the Notification route. The submission process starts with the protocol requesting B-GMP certification for risk class III/ IV devices subjected to the Registration route. Still, the actual register is conditioned to the publication of the B-GMP certificate, which applies to every factory unit and requires an on-site audit by ANVISA. A B-GMP 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. An MDSAP certificate is considered an excellent reference to accelerate B-GMP certification approval. However, it doesn’t replace it.
ANVISA Certification
INMETRO certification
ANVISA requires that certain medical devices, such as electro-medical devices subject to IEC 60601, are certified by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO). INMETRO itself does not conduct certification; it is an accredited Certification Bodie. Tests for electro-medical products performed outside Brazil are usually accepted if based on recognized standards. Certified products will present an INMETRO mark.
ANVISA Certification
ANATEL certification
ANVISA also requires that medical devices and/or their accessories that have telecommunications modules in their technical characteristics, such as wireless communication modules, Bluetooth, wifi, a cellular interface, etc., using telecommunication/wireless communication, are certified by the National Agency for Telecommunications (ANATEL).
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
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Language requirements
How to communicate with the authorities?
The submission documentation can be set up in Portuguese, English, or Spanish. However, the label and the IFU must be written in Portuguese. In addition, ANVISA publishes its resolutions in Portuguese as well.
Qserve presents Brazilians in the team who can help with ANVISA communication.
Regulatory timelines and fees
How long does it take to enter
the Brazilian medical device market?
Fees and timelines required to register a medical device in Brazil can vary significantly depending on various factors, including the complexity of the device, the quality of the documentation submitted, the device's risk class, and the efficiency of the submission process.
Important links and guidance documents
Where to find more information?