Recent Regulatory Changes
This page tracks significant recent changes to ANVISA's medical device regulatory framework. Check back regularly — ANVISA regulations change frequently.
Major recent changes
2022 Regulatory Modernisation Package
The most significant recent change was the October 2022 regulatory modernisation, which replaced the former RDC 185/2001 framework with a new suite of regulations:
| New regulation | Replaced |
|---|---|
| RDC 751/2022 — Registration | RDC 185/2001 |
| RDC 752/2022 — GMP (CBPF) | RDC 16/2013 |
| RDC 753/2022 — Adverse events & recalls | RDC 67/2009 |
| RDC 754/2022 — Labelling | RDC 16/2013 |
| RDC 755/2022 — AFE | RDC 25/2008 |
All new device registrations must comply with the 2022 RDC package. Existing registrations obtained under the former framework are subject to transition provisions.
Transition timeline
ANVISA set transition timelines for existing registrations to comply with the 2022 regulations. Check the ANVISA website and consult your regulatory affairs team for the specific transition deadline applicable to your registered devices.
Ongoing developments (as of May 2026)
- ANVISA UDI implementation: Public consultation on UDI framework ongoing — check ANVISA's consultation portal.
- AI/ML SaMD guidance: ANVISA is finalising guidance on AI/ML-based SaMD — draft available for comment.
- eIFU: ANVISA has been consulting on allowing electronic IFU for certain device classes.
Official resources
Verify all information against official ANVISA sources before making regulatory decisions.