Brazil ANVISA High-Risk Device Registration: Navigating Public Consultation 1248

Medical Device Global Market Access · Sep 25, 2026 · 5m

Brazil's ANVISA has released Public Consultation No. 1248, proposing a major overhaul of the registration process for Class III and IV high-risk medical devices. This episode breaks down the key changes, including the shift to an IMDRF-aligned technical dossier, heightened requirements for clinical evidence and risk management, and the critical 45-day feedback period closing in October 2026. We discuss who is affected and outline practical steps for manufacturers to prepare and provide feedback before the deadline. Key Questions: - What is ANVISA's Public Consultation No. 1248 and what does…