ANVISA Updates Manual for Medical Device Registration in Brazil

Brazilian authority ANVISA has released a revised version of its manual for registering medical devices—the Manual para Registro de Materiais de Uso em Saúde (2ª edição revisada – 2023). This update clarifies regulatory expectations across several key areas, supporting manufacturers in preparing compliant submissions for the Brazilian market.

Key updates include:

• Streamlined guidance on classification and nomenclature, including clearer alignment with the Global Medical Device Nomenclature (GMDN).

• Expanded explanations of required documentation for technical dossiers, emphasizing risk class, device family grouping, and clinical evidence.

• New structure for registration pathways based on risk classes I–IV (aligning with RDC No. 185/2001 and RDC No. 751/2022).

• Clearer definitions for concepts like "kit" and "system", which impact grouping strategies.

• Guidance on electronic submission via the Solicita system, now mandatory for many applications.

What this means for manufacturers:

If you're targeting the Brazilian market, this manual is a must-read. It reflects ANVISA’s continued shift toward harmonized and transparent regulatory practices, but also introduces stricter documentation expectations—especially for risk class III and IV devices. Manufacturers will need to revisit how they structure their technical documentation and ensure alignment with the updated terminology and definitions.

Access the manual directly (in Portuguese) below.