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Brazil's IVD Shake-up: ANVISA RDC 830/2023 and New Risk Classifications
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…
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