SaMD Classification in Brazil
Software qualifies as a medical device under RDC 751/2022 if it is intended to diagnose, prevent, monitor or treat a disease or condition, or provides clinical decision support that drives clinical action.
ANVISA aligns with the IMDRF SaMD classification framework (IMDRF/SaMD N12):
| IMDRF significance | IMDRF healthcare situation | Likely ANVISA class |
|---|---|---|
| Treat or diagnose | Critical | Class IV |
| Treat or diagnose | Serious | Class III |
| Drive clinical management | Critical | Class III |
| Inform clinical management | Serious | Class II |
| Inform clinical management | Non-serious | Class I |
ANVISA expects manufacturers of AI/ML SaMD to include a change management protocol in the technical dossier, particularly for continuously learning algorithms.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.