Medical Devices — Brazil

Brazilian medical device registration is a national registration system led by the Brazilian National Health Surveillance Agency (ANVISA). To enter the Brazilian market, medical devices must complete filing or registration with ANVISA, which is referred to as ANVISA registration for short. ANVISA classifies medical devices into four categories based on product risk: Class I (low risk), Class II (low-to-medium risk), Class III (medium-to-high risk), and Class IV (high risk). Different risk levels correspond to different market access procedures: Class I and Class II adopt the relatively simpler notification procedure; Class III and Class IV adopt the formal registration procedure, where enterprises must submit a complete technical dossier via the Solicita system, including clinical evaluation reports, test data, risk management documents, etc. ANVISA will conduct a full technical review.

According to the provisions of RDC 751/2022 (general medical devices) and RDC 830/2023 (IVD), ANVISA adopts a risk-based classification system that is highly similar to the EU MDR / IVDR. BGMP Certification: For manufacturers of Class III and Class IV devices, ANVISA on-site BGMP audit is generally required. If the manufacturer holds a valid MDSAP certificate, ANVISA may exempt the on-site audit and complete BGMP certification only through document review. INMETRO Certification: The Brazilian National Institute of Metrology, Standardization and Industrial Quality (INMETRO) mandates certification for electronic and electrical medical products. ANATEL Certification: For devices with specific functions such as Bluetooth, Wi-Fi, and radio frequency (RF), certification from the Brazilian National Telecommunications Agency (ANATEL) is mandatory.

Quality management system requirements: It is recommended that Class I and Class II medical devices hold an ISO 13485 certificate, while Class III and Class IV medical devices are required to obtain BGMP certification or an MDSAP certificate. Brazilian ANVISA is an official member of MDSAP, and for manufacturers that have already obtained an MDSAP audit report, ANVISA may grant an exemption from on-site audit. Technical document requirements: In accordance with IMDRF format, documents need to include product specifications, design descriptions, performance test reports, clinical evaluation materials (high-risk products may require local clinical data or equivalence demonstration), and risk management documents. ANVISA requires that all submitted official documents must be in Portuguese in principle, and non-Portuguese documents require notarized translation. Labels and instructions for use are mandatorily required to have a Portuguese version. Simplified procedure: According to Normative Instruction No. 290/2024 (IN 290/2024), Class III and Class IV medical devices and in vitro diagnostic devices already certified by recognized overseas regulatory authorities (Japan MHLW, Canada HC, Australia TGA, USA FDA) are allowed to enjoy simplified registration based on their overseas certification. It should be noted that if the device was marketed through a similar simplified pathway by the recognized overseas regulatory authority, this instruction does not apply, and the device will be reviewed and registered through the normal procedure in Brazil.