Software & AI/ML — SaMD in Brazil
See SaMD Classification for classification details and Digital Health & SaMD for ANVISA's broader digital health framework.
Key SaMD regulatory requirements
- Classification under RDC 751/2022 using the IMDRF-aligned SaMD classification
- Full IEC 62304 software lifecycle documentation
- ISO 14971 risk management incorporating software-specific hazards
- Usability engineering per IEC 62366-1
- Cybersecurity documentation addressing security risks
- Change management protocol — especially for AI/ML algorithms with potential to evolve
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.