Episode Details

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 market access requirements. Key Questions: - What is ANVISA's Public Consultation No. 1,248 and why is it important for device manufacturers? - Which specific medical device classes are affected by this proposed Brazilian regulation? - How will technical dossier requirements for high-risk devices change under the new proposal? - What is the deadline for submitting feedback to ANVISA on these proposed changes? - What are the new requirements for clinical evidence, risk management, and software validation? - How does this proposal aim to align Brazil's regulations with international standards like IMDRF? - What are the four key actions manufacturers should take immediately to prepare? - What role does the Brazilian Registration Holder (BRH) play in this new process? 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: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in Brazil and over 30 other markets, developing efficient regulatory strategies and preparing technical dossiers for submission to authorities like ANVISA. Our team of local experts, supported by advanced AI, helps you navigate complex requirements, maintain compliance, and accelerate your time to market. For support with your Brazilian market access strategy, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI tools and device database at https://pureglobal.ai.