Brazil ANVISA SaMD Regulation Update: Preparing for Changes to RDC 657/2022

Brazil's health agency, ANVISA, has announced its 2026-2027 regulatory agenda, which includes a significant revision to the rules for Software as a Medical Device (SaMD), RDC 657/2022. This episode explores the reasons for the update, the potential changes manufacturers can expect regarding AI/ML validation and cybersecurity, and the practical steps regulatory affairs and quality teams should take now to prepare for the upcoming public consultations and new requirements. Key Questions: - What are ANVISA's key regulatory priorities for 2026-2027? - Why is Brazil planning to update its SaMD regulation, RDC 657/2022? - Which types of SaMD manufacturers will be most affected by these changes? - What new requirements related to AI/ML and cybersecurity can we expect in the revised rule? - How will the new rules likely align with international standards from the IMDRF? - When can companies expect public consultations on the draft regulation? - What practical steps should regulatory teams take now to prepare? - How can a proactive gap analysis help in preparing for the new ANVISA rules? Sources: - https://www.emergobyul.com/blog/2026/01/brazil-anvisa-announces-priorities-2026-2027-year - https://www.pure-global.com/post/anvisa-s-international-cooperation-and-regulatory-convergence-are-reshaping-brazil-s-medical-device-market - https://www.mattosfilho.com.br/en/unico/anvisa-approves-new-regulatory-framework-for-software-as-a-medical-device/ How Pure Global can help: Pure Global provides end-to-end regulatory consulting for MedTech and IVD companies, helping you navigate complex market access challenges like ANVISA's upcoming SaMD regulation changes. Our local experts in Brazil can act as your official representative, develop a clear regulatory strategy, and use advanced AI to compile and manage your technical submissions efficiently. We monitor regulatory changes in real-time to ensure you are always prepared. Whether you are a startup or a multinational, we streamline your path to market in Brazil and over 30 other countries. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and regulatory database at https://pureglobal.ai to learn more.