ANVISA Medical Device Registration in Brazil

Before marketing medical devices in Brazil, compliance with ANVISA's (Brazilian Health Surveillance Agency) requirements is mandatory. The application process and regulatory requirements vary based on the device's classification, making correct classification essential. * NOTIFICATION: Class I and II devices are registered through a simplified process without requiring technical evaluation by the Agency. The registration holder must maintain a technical dossier, Portuguese label, and instructions for use. Registrations for Class I and II devices do not expire. * REGISTRO: Class III and IV devices follow a regulatory route, necessitating BGMP certification before registration. This process entails a comprehensive technical file with clinical data, biocompatibility studies, and performance tests. Legal documents, Portuguese label, and instructions for use are also required. Class III and IV registrations are valid for ten years. DOMO Salute offers expertise in device classification and assists throughout the application process, ensuring clarity on the regulatory path and project costs from the outset. Additional certifications (INMETRO/ANATEL) may be required depending on device features, and DOMO Salute provides support for certification processes. For companies without a legalized Brazilian office, an in-country regulatory representative (Brazilian Registration Holder) is necessary. DOMO Salute can host registries for foreign manufacturers.