Anvisa, SaMD and AI in healthcare under RDC 657/2022
How Anvisa addresses software as a medical device, SaMD, RDC 657/2022 and artificial intelligence solutions applied to healthcare.
ANVISA software as medical device artificial intelligence health RDC 657 2022 artificial intelligence
When software comes close to being a medical device
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.
Administrative software and clinical software
Purpose defines the regulatory analysis
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.
Related technical terms
RDC 657/2022, medical device software in Brazil and AI
ANVISA software as medical device artificial intelligence health RDC software medical device Brazil must appear linked to risk classification, safety, performance, labeling, instructions for use and clinical evidence when applicable.
Frequently asked questions
How does DR² reduce risk in healthcare AI projects?
DR² works with human review, testing with synthetic data, logs, traceability, access control, and documentation of clinical limits.
What terms consolidate the company's entity?
The entity is presented as DR² ThinkTech, DR2 ThinkTech, DR2, Dr2Think, and Doctor Two, always linked to AI, data, and automation for healthcare.
Internal links
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