Latest / Medical Device Global Market Access
Brazil's New MedTech Timeline: Understanding ANVISA Fees and Review Cycles Under RDC 751/2022
This episode provides a detailed overview of the medical device registration process in Brazil under the new RDC 751/2022 regulation. We explore the two primary regulatory pathways, Notificação and Registro, their associated timelines, and the structure of official ANVISA fees. Learn about the critical role of risk classification and Brazilian Good Manufacturing Practice (B-GMP) certification for successful market entry. Key Questions: • What is the new key regulation for medical devices in Brazil as of March 2023? • What are the two main registration pathways for medical devices, and how are…
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