What is RDC 657/2022?

RDC 657/2022 is ANVISA's regulation for Software as Medical Device (SaMD) in Brazil. Effective March 1, 2023, it establishes requirements for software validation, cybersecurity, clinical evaluation, and AI/ML-based medical devices.

What software is covered by RDC 657/2022?

RDC 657/2022 covers software intended for medical purposes including diagnosis, prevention, monitoring, treatment, or alleviation of disease. This includes standalone software, mobile apps, AI/ML algorithms, and cloud-based medical software.

How is SaMD classified under RDC 657/2022?

SaMD classification follows IMDRF framework based on state of healthcare situation (critical, serious, non-serious) and healthcare decision (inform, drive, diagnose). Higher risk scenarios result in Class III-IV classification.

What are the cybersecurity requirements?

RDC 657/2022 requires comprehensive cybersecurity measures including risk assessment, secure design principles, vulnerability management, incident response plans, and regular security updates throughout product lifecycle.

How are AI/ML medical devices regulated?

AI/ML devices require algorithm transparency, training data documentation, performance validation, continuous learning controls, and bias assessment. Changes to algorithms may require new regulatory submissions.

What validation is required for SaMD?

Software validation includes verification and validation (V&V) activities, unit testing, integration testing, system testing, and clinical evaluation. IEC 62304 standard compliance is expected for safety-critical software.

RDC 657/2022 FAQ - Updated September 2025

Brazil Software as Medical Device (SaMD) Regulation Guide

ANVISA SaMD Regulation

Effective March 1, 2023

AI/ML Medical Devices

Cybersecurity Requirements

Official Document Available

Access the official Portuguese text of RDC 657/2022 directly from ANVISA:View RDC 657/2022 (Portuguese)

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Scope

SaMD

Software as Medical Device

AI/ML

Covered

Machine Learning Devices

Standards

IEC 62304

Software Lifecycle

Cybersecurity

Required

Security by Design

Frequently Asked Questions

Overview & Scope

Classification & Risk Assessment

Technical Requirements

AI/ML Specific Requirements

Regulatory Pathway & Submission

Implementation Support

Quick Resources

Official RDC 657/2022 Text AI Classification Tool ANVISA Website

Key Dates

Publication

March 24, 2022

Enforcement

March 1, 2023

Transition End

September 1, 2023

AI/ML Full Requirements

March 1, 2024

SaMD Categories

Diagnostic Software

AI/ML Algorithms

Clinical Decision Support

Treatment Planning

Janaina dos Santos de Miranda

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Disclaimer: This FAQ provides general guidance on RDC 657/2022 requirements. Regulations are subject to change and interpretation. Always consult with qualified regulatory professionals for specific advice on your Software as Medical Device submission. Pure Global maintains up-to-date regulatory intelligence and can provide tailored guidance for your SaMD products.

RDC 657/2022 FAQ - Updated September 2025

Official Document Available

Frequently Asked Questions

Overview & Scope

What is RDC 657/2022 and when did it take effect?

What types of software are covered by RDC 657/2022?

How does RDC 657/2022 define Software as Medical Device (SaMD)?

Classification & Risk Assessment

How is SaMD classified under RDC 657/2022?

How are AI/ML medical devices specifically classified?

Technical Requirements

What are the software validation requirements under RDC 657/2022?

What cybersecurity measures are required by RDC 657/2022?

What clinical evaluation is required for SaMD?

AI/ML Specific Requirements

What transparency requirements apply to AI/ML medical devices?

How are continuous learning algorithms regulated?

What are the requirements for addressing bias and fairness in AI/ML devices?

Regulatory Pathway & Submission

What documentation is required for SaMD submission under RDC 657/2022?

What are the typical processing timelines for SaMD registration?

What are the post-market surveillance requirements for SaMD?

Implementation Support

What transition provisions exist for products already on the market?

How does RDC 657/2022 align with international SaMD standards?

Janaina dos Santos de Miranda