Global Regulatory Brazil can help you obtain regulatory approval from ANVISA (RDC No. 751/2022) to sell medical devices in the Brazilian market.
Brazil’s ANVISA medical device regulations Brazil is the largest medical device market in Latin America, with an established but complex regulatory system. Medical devices in Brazil are regulated by the National Health Surveillance Agency (ANVISA).
This update revokes RDC 185/2001 (classification rules and procedures for Registro – class III and IV medical devices) and RDC 40/2015 (procedures for Notification and technical dossier – risk class I and II medical devices).
The new resolution also includes the requirements for Brazilian Good Manufacturing Practices’ (B-GMP) proof of compliance. Brazil’s New RDC 751/2022 Incorporates European MDR Risk Classification Rules Brazilian regulators align medical device classification rules to those of EU MDR.
What is a Brazilian Registration Holder?
Manufacturers of medical devices of foreign origin that do not have a physical location in Brazil must appoint a Brazil Registration Holder (BRH). Your BRH will submit your application for registration to ANVISA and will maintain control of your device registration and Brazil Good Manufacturing Practices (B-GMP) certification, if applicable.
- Registration deadlines vary based on the classification of your device please refer to our freely available regulatory table in Brazil for a more detailed analysis of ANVISA registration deadlines.
- The transfer of registration to another Registration Holder in Brazil is regulated by RDC 102/2016, allows greater flexibility for registration transfers, however you must follow all Anvisa guidelines.
What Should a BRH do?
- The BRH and their regulatory team should determine the correct classification of their medical device according to Brazilian Regulations.
- With their Operating License the BRH submits the Submission to Anvisa
- The BRH imports the Medical Device into Brazil
- The BRH is in charge of post market surveillance ( Safety & Quality) of the device.
- The BRH must maintain the License and GMP
Picking the Right BRH
- Hiring an independent BRH instead of a distributor gives you the freedom to change distributors and add as many distributors as possible in the Brazilian Network. Reaching more of the Brazilian Market.
- Hiring an independent BRH instead of a distributor will have more security over your product license.
- Transfer from one BRH to another must be agreed upon by the first BRH. If the BRH does not agree to the transfer, there is no legal method a foreign manufacturer can force the local BRH to make the transfer.
Registration Routes in Brazil
The BRH and their regulatory team should determine the correct classification of their medical device according to Brazilian Regulations.
REGISTER: Class I and II devices
- Follow the Notification route, which includes a simplified application and requires no review by ANVISA.
- Brazilian Registration Holder (BRH) is necessary for Notification
- You must submit an application and the required documents to ANVISA
- Manufacturers must support and share a complete technical dossier for their Brazilian Registration Holder (BRH).
- A BRH must always keep on file, along with the Brazilian dossier, labeling and IFUs, in case of an on-site inspection by ANVISA.
- Class I and II registrations do not expire.
REGISTER: High-risk Class III and Class IV devices
- Follow the registration process.
- Brazilian Registration Holder (BRH) is necessary for Registration
- Manufacturers must prepare a Technical File that includes clinical data, clinical studies, and additional information about the devices.
- A BRH must always keep on file, along with the Brazilian dossier, Legal Documents, labeling and IFUs, in case of an on-site inspection by ANVISA.
- Class III and Class IV registrations expire after ten years.
- INMETRO certification is often required for electromedical devices subject to IEC 60601, as well as some other medical devices.
- ANVISA requires certain medical devices to be certified by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), which is responsible for establishing technical standards in Brazil.
Learn more about
GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.