Brazil's New e-Notivisa System: ANVISA's Overhaul of Medical Device Adverse Event Reporting

On July 1, 2026, Brazil's ANVISA mandated the use of its new e-Notivisa system for all medical device adverse event reporting, replacing the legacy NOTIVISA platform. This episode details the critical changes, including the adoption of the International Medical Device Regulators Forum (IMDRF) adverse event coding, which aligns Brazil's technovigilance requirements with global standards. We discuss the implications for manufacturers and Brazil Registration Holders (BRHs) and provide practical steps for updating quality systems, training teams, and ensuring compliance with the new structured data requirements. Key Questions: - What is the new e-Notivisa system launched by Brazil's ANVISA? - When did the e-Notivisa system become mandatory for adverse event reporting? - How does e-Notivisa change technovigilance requirements in Brazil? - What are the key differences between e-Notivisa and the old NOTIVISA system? - How does the adoption of IMDRF adverse event codes impact manufacturers? - Why is this new system important for global regulatory harmonization? - What immediate actions should manufacturers and Brazil Registration Holders take? - How should quality and regulatory teams update their procedures for the new system? Sources: - https://www.emergobyul.com/news/brazil-anvisas-new-e-notivisa-system-major-shift-medical-device-vigilance How Pure Global can help: Pure Global offers 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, managing post-market surveillance and ensuring compliance with evolving regulations like ANVISA's e-Notivisa system. Our experts can help update your QMS, train your team on IMDRF coding, and manage all submissions to keep your products on the market. Leverage our local expertise and advanced AI tools to navigate complex regulatory landscapes efficiently. Contact us at [email protected], visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.