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ANVISA's Digital Health Regulatory Framework

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ANVISA has been developing a dedicated digital health regulatory framework through a series of public consultations and technical publications. As of May 2026, the framework is still evolving — with the core device regulation (RDC 751/2022) applying to SaMD, and specific 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​

InstrumentContent
RDC 751/2022Core regulation — applies to all medical devices including SaMD
ANVISA Nota Técnica on SaMDANVISA's interpretation of the SaMD definition and classification
IMDRF SaMD N12Classification framework adopted by ANVISA
ANVISA digital health consultationOpen 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.