Brazil ANVISA High-Risk Device Registration: Public Consultation No. 1,248 Explained

Medical Device Global Market Access · Sep 8, 2026 · 5m

This episode details Brazil ANVISA's Public Consultation No. 1,248, published on August 26, 2026, which proposes a new regulatory framework for the registration of Class III and IV high-risk medical devices. We discuss the key changes to technical documentation requirements, the move to align with international standards, the impact on manufacturers and their Brazilian Registration Holders (BRH), and the critical 45-day feedback period closing in October 2026. Learn the practical steps your regulatory and quality teams should take now to prepare for these significant updates to Brazil's…