ANVISA Medical Device & SaMD Regularization Manual 2025 Update

Brazil’s National Health Surveillance Agency (ANVISA) released an updated Manual for the Regularization of Medical Equipment and Software as a Medical Device (SaMD) on January 12, 2025. The updated guidance clarifies how medical devices and medical software must be regularized in Brazil, helping manufacturers, importers, and legal representatives navigate device classification, regulatory pathways, and ANVISA registration or notification requirements more efficiently.

Key Updates in the 2025 ANVISA Regularization Manual

The updated manual reflects Brazil’s current medical device regulatory framework and consolidates existing rules into a single, practical reference document. Key highlights include:

• Clear differentiation between registration and notification pathways

• Updated guidance on medical device and SaMD risk classification

• Detailed explanations of technical and administrative documentation

• Step-by-step instructions for submissions through ANVISA systems

By improving clarity and consistency, ANVISA aims to reduce misinterpretation and delays during the regularization process.

Regulatory Pathways for Medical Devices and SaMD in Brazil

One of the manual’s core objectives is to help companies determine the correct regulatory pathway for their products. Depending on the risk classification, medical devices and software may be subject to:

• Notification (Notificação) for lower-risk products

• Registration (Registro) for higher-risk products

The manual explains how the intended use, technological characteristics, and risk profile influence this determination—particularly important for Software as a Medical Device (SaMD).

Medical Device and Software Classification Criteria

Correct classification is a critical step in Brazilian regulatory compliance. The manual outlines how ANVISA applies risk-based classification rules to both physical medical equipment and standalone software.

For SaMD, special attention is given to:

• Intended medical purpose

• Impact on clinical decision-making

• Potential risk to patient safety

Accurate classification directly affects registration requirements, including documentation requirements, review timelines, and post-market obligations.

Documentation Requirements for ANVISA Regularization

The updated manual provides detailed guidance on the documentation required for each regulatory pathway, including:

• Technical dossiers demonstrating safety and performance

• Labeling and instructions for use

• Quality management system evidence

• Software lifecycle documentation for SaMD

This structured approach helps regulatory professionals prepare more complete and compliant submissions.

Impact on Manufacturers, Importers, and Legal Representatives

The revised guidance is particularly relevant for:

• Foreign manufacturers entering the Brazilian market

• Importers and distributors responsible for local compliance

• Brazilian legal representatives acting on behalf of overseas companies

• Regulatory affairs teams managing ANVISA submissions

By consolidating expectations into a single manual, ANVISA improves predictability and supports faster market access for compliant products.

How to Prepare for Compliance with the Updated ANVISA Manual

Companies operating in Brazil should take the following steps:

1. Review product portfolios to confirm correct classification

2. Assess whether products require registration or notification

3. Update technical documentation to align with the manual

4. Ensure SaMD documentation reflects software-specific regulatory expectations

Early alignment with the updated guidance can help prevent rework, delays, and regulatory queries.

Access the Official ANVISA Manual

The full manual is available on ANVISA’s official website:

Manual for the Regularization of Medical Equipment and Software as a Medical Device at ANVISA — Brazilian Health Regulatory Agency (ANVISA)

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