ANVISA's Digital Health Regulatory Framework
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ANVISA has established a dedicated digital health regulatory framework through RDC 752/2022 (specific regulation for software as a medical device) and a series of public consultations and technical publications. The framework continues to evolve — with the core device regulation (RDC 751/2022) applying to all medical devices including SaMD, RDC 752/2022 providing specific requirements for software, and additional guidance being developed for AI/ML, mobile health, and connected devices.
ANVISA's approach to digital health
ANVISA takes a risk-based, use-case-driven approach to digital health regulation:
- If software is intended for a medical purpose (diagnosis, treatment, monitoring) → it is a medical device and requires ANVISA registration.
- If software is a general wellness or administrative tool → it is not a medical device and does not require registration.
- The intended purpose stated by the manufacturer determines which category applies.
Key regulatory instruments
| Instrument | Content |
|---|---|
| RDC 751/2022 | Core regulation — applies to all medical devices including SaMD |
| ANVISA Nota Técnica on SaMD | ANVISA's interpretation of the SaMD definition and classification |
| IMDRF SaMD N12 | Classification framework adopted by ANVISA |
| ANVISA digital health consultation | Open consultation on AI/ML, mobile health, and cybersecurity guidance |
ANVISA's digital health team
ANVISA has a dedicated digital health team within GPRODS that handles:
- Classification inquiries for software and digital health products;
- Technical review of SaMD registration dossiers; and
- Development of guidance and regulatory framework for digital health.
Official resources
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.