Recent Amendments & Revogações (Repeals)
ANVISA regulations change frequently. This page summarises significant recent amendments and repeals relevant to medical device regulation.
The 2022 regulatory modernisation
The most significant recent change was the 2022 regulatory modernisation package, which replaced the former RDC 185/2001 framework with a new suite of regulations:
| Former regulation | Replaced by |
|---|---|
| RDC 185/2001 (registration) | RDC 751/2022 |
| RDC 16/2013 (GMP) | RDC 752/2022 |
| RDC 67/2009 (adverse events) | RDC 753/2022 |
| RDC 16/2013 (labelling) | RDC 754/2022 |
| RDC 25/2008 (AFE) | RDC 755/2022 |
The 2022 package introduced stricter clinical evidence requirements, a more structured PMS framework, and closer alignment with international standards (IMDRF, ISO).
Monitor the What's New section for ongoing regulatory changes.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.