Brazil's New MedTech Timeline: Understanding ANVISA Fees and Review Cycles Under RDC 751/2022
Medical Device Global Market Access · Pure Global
July 7, 20253m 53s
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Show Notes
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 they different?
• How long does the ANVISA review process take for low-risk devices?
• What is the expected timeline for high-risk device registration?
• What was the critical submission deadline of February 29, 2024?
• How are the official application fees determined by ANVISA?
• Is Brazilian GMP certification required for all device classes?
• What is a Brazil Registration Holder (BRH) and why are they essential?
Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.