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