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 is ultimately responsible for technovigilance reporting to ANVISA?

- What are the specific reporting timelines for different types of adverse events?

- What happens if a serious adverse event occurs outside of Brazil with a device sold in the country?

- Are malfunctions that haven't caused harm required to be reported?

- Why is a proactive post-market surveillance system crucial for market access in Brazil?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. We act as your local representative in over 30 markets, including Brazil, ensuring your post-market surveillance and technovigilance systems are fully compliant with ANVISA's requirements. Our experts manage adverse event reporting and field safety corrective actions, navigating complex timelines so you can maintain market presence securely. Leveraging advanced AI, we make compiling and managing technical documentation efficient and accurate. For expert guidance on entering and staying in the Brazilian market, contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and database at https://pureglobal.ai.