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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.

For AI/ML-based SaMD, ANVISA requires: documentation of training data sources and characteristics, validation across different patient populations, procedures for algorithm updates and versioning, documented performance monitoring post-market, and change management that triggers new clinical validation if algorithm modifications alter intended use or performance beyond pre-defined parameters.