This episode provides a detailed analysis of Brazil's new IVD regulation, ANVISA RDC 830/2023, which was implemented in June 2024. We explore the critical changes to risk classification systems, which align with international standards and result in the up-classification of many devices. The discussion covers the impact on regulatory pathways, technical documentation, and labeling, offering essential insights for manufacturers to ensure continued market access in Brazil.

- What is Brazil's new RDC 830/2023 for IVD devices?

- When did this new ANVISA regulation take effect?

- How does the new risk classification system impact IVD manufacturers?

- Why are many IVD devices being moved to higher risk classes in Brazil?

- What is the difference between the 'notificação' and 'registro' pathways?

- What are the new labeling requirements under RDC 830/2023?

- How should your company prepare for these regulatory changes in Brazil?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access. With Brazil's new RDC 830/2023 creating significant shifts, our local experts and advanced AI tools are essential for navigating the updated risk classifications and registration requirements. We act as your local representative in over 30 markets, including Brazil, developing efficient regulatory strategies and compiling technical dossiers to ensure compliance and speed to market. Let us help you navigate this changing landscape. Contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.