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Navigating Brazil's ANVISA Technovigilance: A Deep Dive into RDC 67/2009 Reporting Timelines
This episode provides a detailed overview of Brazil's key technovigilance regulations for medical devices, RDC 67/2009 and RDC 551/2021. We explore the mandatory requirements for post-market surveillance, the critical role of the Brazilian Registration Holder (BRH), and the specific, strict timelines set by ANVISA for reporting adverse events, malfunctions, and field safety corrective actions to ensure continued compliance and patient safety in the Brazilian market. - What is the primary purpose of Brazil's RDC 67/2009? - How does RDC 551/2021 complement the requirements of RDC 67/2009? - Who…
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