Upcoming Changes & Transition Timelines
This page summarises known upcoming regulatory changes and active transition timelines for Brazil's medical device regulatory framework.
Known upcoming changes (as of May 2026)
| Topic | Status | Expected timeline |
|---|---|---|
| UDI implementation | Consultation ongoing | TBC — monitor ANVISA portal |
| AI/ML SaMD guidance | Draft guidance in development | TBC |
| eIFU framework | Under consideration | TBC |
| MERCOSUL harmonisation updates | GMC working group active | Progressive |
| Cybersecurity guidance | Scoping phase | TBC |
Active transition timelines
The 2022 RDC package (RDC 751–755/2022) included transition provisions for products registered under the former framework. Check the specific transition provisions in each RDC for the deadlines applicable to your device category and registration class.
Transition deadlines are set by ANVISA and may be updated. Always verify current transition timelines against the official ANVISA text and consult with a qualified Brazilian regulatory affairs professional.
Staying up to date
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Subscribe to ANVISA's email notification service for new publications.
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Monitor the ANVISA website daily/weekly.
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Join relevant industry association mailing lists (ABIMO, SBCTA).
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Consider engaging a Brazilian regulatory affairs consultant to monitor on your behalf.
Verify all information against official ANVISA sources before making regulatory decisions.