Software as a Medical Device (SaMD) — Brazil Position
Is your software a medical device in Brazil?
Under RDC 751/2022, software qualifies as a medical device (produto para saúde) in Brazil when it is intended by the manufacturer to be used, alone or in combination, for a medical purpose — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
Software that does not qualify as a medical device:
- General hospital administration software (EHR, scheduling, billing — without clinical decision functions);
- Wellness and fitness apps with no diagnostic or therapeutic claims;
- Software used solely for device operation (embedded firmware); and
- Laboratory information management systems (LIMS) without diagnostic decision functions.
Classification of SaMD in Brazil
See SaMD Classification for the full classification approach aligned with IMDRF N12.
Registration dossier for SaMD
A SaMD registration dossier under ANVISA must include all standard medical device documentation (device description, intended purpose, essential requirements, risk management) plus SaMD-specific documentation:
- IEC 62304 software lifecycle documentation
- IEC 62366-1 usability engineering documentation
- Cybersecurity risk assessment and controls
- Clinical evidence demonstrating the SaMD performs as intended
- For AI/ML SaMD: change management protocol
Official resources
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.