Brazil's Regulatory Reset: A Guide to RDC 751/2022
Medical Device Global Market Access · Pure Global
August 20, 20253m 20s
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Show Notes
This episode unpacks Brazil's landmark medical device regulation, RDC 751/2022. We explore the key updates that align Brazil with global standards, including the new risk classification rules, the shift to an IMDRF-based Technical Dossier, and critical transition deadlines for manufacturers.
Key Questions:
• What major changes does RDC 751/2022 introduce for MedTech companies?
• How do the new risk classification rules compare to the EU MDR?
• What is the "Table of Contents" format, and how does it affect your technical file?
• Did you meet the crucial February 29, 2024, deadline for up-classified devices?
• Are there new provisions for Software as a Medical Device (SaMD)?
• What are the updated labeling and Instructions for Use (IFU) requirements?
• How do the Notificação and Registro pathways differ under the new resolution?
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.