Latest / Medical Device Global Market Access
ANVISA RDC 751/2022: A Manufacturer's Guide to Brazilian Device Registration
This episode provides a detailed overview of Brazil's pivotal medical device regulation, ANVISA RDC 751/2022, which became effective in March 2023. We explore its comprehensive framework, including the four-tier risk classification system, the distinct pathways for notification and registration, and its alignment with international standards like the IMDRF Table of Contents. The host also discusses modernized rules for Software as a Medical Device (SaMD) and what these significant changes mean for manufacturers seeking market access in Brazil. - What is ANVISA's RDC 751/2022 and why is it…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.