Episode Details

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 it propose for high-risk devices? - How will the technical dossier structure for Class III and IV devices change in Brazil? - What new requirements for clinical evidence and risk management are being introduced? - How does this proposal align Brazil's regulations with international standards like IMDRF? - What is the deadline for submitting feedback on this important consultation? - Which device manufacturers will be most impacted by these regulatory changes? - What immediate actions should regulatory and quality teams take to prepare? - How can manufacturers effectively provide input to ANVISA before the final rule is published? - What are the long-term implications for market access in Brazil? Sources: - https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/cp-propoe-nova-regra-para-registro-de-dispositivos-medicos - https://www.gov.br/anvisa/pt-br/assuntos/consultas-publicas/consultas-publicas-em-andamento How Pure Global can help: Navigating Brazil's evolving regulatory landscape for high-risk devices requires local expertise and strategic planning. Pure Global provides end-to-end support for ANVISA submissions, from developing a regulatory strategy and conducting gap analyses to compiling and submitting technical dossiers. Our team of local experts in Brazil, combined with advanced AI tools, ensures your submissions are compliant with the latest requirements, minimizing delays and accelerating your path to market. Contact us at info@pureglobal.com or visit https://pureglobal.com to learn more. Explore our free AI regulatory intelligence tools and device database at https://pureglobal.ai.