Brazil ANVISA's New Notification Guidance: What Class I/II Medical Device and IVD Manufacturers Need to Know

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Brazil ANVISA's New Notification Guidance: What Class I/II Medical Device and IVD Manufacturers Need to Know

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Brazil's ANVISA has published two new guidance manuals detailing the 'notification' pathway for Class I and II medical devices and IVDs. This episode explains how these manuals, released on August 25, 2023, clarify the submission processes under RDC 751/2022 and RDC 830/2023, what practical information they contain for manufacturers, and the concrete steps regulatory teams should take to streamline market access for lower-risk products in Brazil. Key Questions: - What are the new ANVISA guidance manuals for the notification pathway? - Which medical device and IVD classes are affected by this new guidance? - How does this guidance clarify the submission process under RDC 751/2022 and RDC 830/2023? - What specific documentation is required for a notification submission in Brazil? - How should manufacturers use ANVISA's electronic portal for notifications? - What are the rules for grouping multiple devices in a single submission? - What are the post-market responsibilities for notified devices in Brazil? - What practical steps should my regulatory team take in response to this new guidance? Sources: - https://www.asphalion.com/news/anvisa-publishes-two-guidance-manuals-for-the-regularisation-of-medical-devices/ 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, managing submissions and ensuring ongoing compliance. Our experts develop efficient regulatory strategies and use advanced AI to compile and submit technical dossiers, helping you navigate complex requirements like ANVISA's notification pathway. From initial market research to post-market surveillance, we ensure your products reach global markets faster. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and regulatory database at https://pureglobal.ai.

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