ANVISA Technovigilance Changes in Brazil: What to Expect After the Public Consultation

This episode covers the recent closure of Brazil ANVISA's public consultation (Call for Contributions No. 4/2026) on a new technovigilance framework. We discuss the implications for medical device manufacturers, the expected changes to adverse event reporting and post-market surveillance, and practical steps to prepare for the upcoming regulations in Brazil. Key Questions: - What does the closing of ANVISA's public consultation on technovigilance mean for the industry? - How will the new framework likely change adverse event reporting in Brazil? - Who is responsible for complying with the upcoming technovigilance requirements? - What are the potential new timelines and definitions for reporting incidents? - How can manufacturers align their current processes with international standards in anticipation of the new rules? - What is the role of the Brazil Registration Holder (BRH) in this new framework? - What practical steps should regulatory and quality teams take right now? - When can we expect the final resolution from ANVISA to be published? Sources: - https://www.demarest.com.br/en/life-sciences-and-healthcare-newsletter-or-june-2026 How Pure Global can help: Pure Global provides comprehensive support for medical device manufacturers navigating complex regulatory landscapes like Brazil. Our experts can help you prepare for ANVISA's new technovigilance requirements, from developing a compliant post-market surveillance strategy to acting as your Brazil Registration Holder (BRH). We combine local expertise with advanced AI tools to streamline dossier preparation, manage submissions, and ensure your products remain compliant. To learn how we can accelerate your market access in Brazil and over 30 other countries, visit us at https://pureglobal.com, contact us at [email protected], or explore our free AI regulatory tools and device database at https://pureglobal.ai.