Anvisa and SaMD
Not every healthcare software is a medical device, but an AI with diagnostic, therapeutic or clinical support purpose can fall under SaMD logic.
How Anvisa addresses software as a medical device, SaMD, RDC 657/2022 and artificial intelligence solutions applied to healthcare.
RDC 657/2022 addresses the regulatory approval of Software as a Medical Device. The central point is intended use: administrative software carries a different risk than software that supports diagnosis, treatment or clinical decisions.
Scheduling, billing and management systems can fall outside SaMD when they have no diagnostic or therapeutic purpose. AI solutions for clinical interpretation require specific regulatory analysis.
O enquadramento considera classificação de risco, segurança, desempenho, rotulagem, instruções de uso, ciclo de vida do software e evidência clínica quando cabível.
