ANVISA resolution on software as a medical device

In forceANVISA RDC 657/2022 (SaMD)

Summary

It requires notifying or registering medical-purpose software with ANVISA by risk class, including software that uses AI. For AI software, ANVISA asks for a justification of the AI technique used. A revision with AI-specific rules is planned. Documents submitted to the ANPD or other Brazilian regulators must be in Portuguese.

Who it applies to

Manufacturers, importers and distributors of medical-purpose software in Brazil.

Penalties

Health sanctions (Law 6,437/1977), including a ban on marketing the product.

Official name: Resolução de Diretoria Colegiada – RDC nº 657, de 24 de março de 2022 – Regularização de software como dispositivo médico (SaMD)
Official reference: RDC nº 657/2022, DOU 30-mar-2022; vigente desde el 1-jul-2022; complementada por la RDC 751/2022
Regulator: National Health Surveillance Agency (ANVISA)
Official source: Check the sourceHow we verify sources

Key dates

March 30, 2022Published in the DOU
July 1, 2022Takes effect

Obligations and dates

Obligations table
Obligation	Article or citation	Status	Date	Who it applies to	Verification
Register AI medical software with ANVISA	RDC ANVISA 657/2022	In force	Already applicable	If you develop, import or distribute AI software for diagnostic, therapeutic or clinical support purposes in Brazil.	Pending confirmation in the official source (last checked: November 4, 2026)

Register AI medical software with ANVISA

RDC ANVISA 657/2022In force

Already applicable

When it relates: If you develop, import or distribute AI software for diagnostic, therapeutic or clinical support purposes in Brazil.
What the rule provides: Classify the software by risk and notify or register it before marketing.
Document and justify the AI technique, training and validation data, and performance.
Keep post-market surveillance of the product.
Typical evidence: Technical file with AI justification.
ANVISA notification or registration.
Related base documents: Clinical and Technical Validation Protocol for Healthcare AI
Model Card
Supporting documents: Dataset Datasheet
AI Post-Deployment Monitoring Plan
Verification: Pending confirmation in the official source (last checked: November 4, 2026)Effective date (July 1, 2022) and the duty to justify the AI technique per secondary sources (Mattos Filho) and an ANVISA presentation to the Chamber (2025). The official text of RDC 657/2022 could not be opened: antigo.anvisa.gov.br, bvsms.saude.gov.br and the DOU did not respond. A revision of the RDC with AI-specific rules is on the 2026-2027 regulatory agenda.