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 and more detailed clinical evidence requirements for device registration; a more structured post-market surveillance (PMS) framework with mandatory PMS plans; enhanced adverse event reporting obligations; and closer alignment with international standards (IMDRF guidelines, ISO 14971 risk management, and ICH clinical data requirements).
Monitor the What's New section for ongoing regulatory changes.
Verify all information against official ANVISA sources before making regulatory decisions.