What is RDC 925/2024 and why is it important?

RDC 925/2024 is ANVISA's regulation for medical device sanitary control. Published December 20, 2024, effective January 2, 2025. Establishes import procedures and customs requirements for all medical devices entering Brazil.

Who must comply with RDC 925/2024?

All entities importing medical devices into Brazil must comply. Includes manufacturers, importers, distributors, and registration holders. Applies to all device classes and types.

When does RDC 925/2024 come into effect?

Published December 20, 2024. Effective January 2, 2025. 13-day implementation period for industry preparation. All imports after this date must comply.

What documentation is required for importing medical devices under RDC 925/2024?

Commercial invoice, packing list, AFE authorization, shipping documents, and health certificates

How does the SISCOMEX system work for medical device imports?

SISCOMEX is Brazil's electronic customs system for declaring and tracking imports in real-time

What are the sanitary control procedures at Brazilian customs?

ANVISA conducts document verification, physical inspections, and compliance checks at ports of entry

What are the typical customs duties and taxes for medical devices?

Import duty (0-16%), IPI (0-15%), PIS/COFINS (11.33%), ICMS (varies by state 7-18%)

How long does customs clearance typically take?

5-15 business days for standard clearance; 20-30+ days if inspections or issues arise

What happens if my shipment is rejected or detained?

Common issues include documentation errors, registration problems, or labeling non-compliance requiring remediation or re-export

Are there any exemptions or special procedures for certain types of imports?

Yes - samples, donations, personal use, and clinical trial products have modified requirements

How do I handle imports for clinical trials or research purposes?

Clinical trial products require separate ANVISA approval beyond standard import procedures

What penalties apply for non-compliance with RDC 925/2024?

Fines from R$2,000-R$1,500,000, shipment seizure, AFE suspension, and potential criminal liability

RDC 925/2024 FAQ - Updated October 2025

Brazil Medical Device Sanitary Control. Expert guidance by Pure Global regulatory specialists

ANVISA Sanitary Control

Effective January 2, 2025

Import Procedures

Customs Requirements

Official Document

Access the official document:Download RDC 925/2024 (Portuguese)

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Scope

All Imports

Medical devices

Effective Date

Jan 2, 2025

Currently in force

Key Process

SISCOMEX

Import system

Processing

5-10 days

Typical timeline

Frequently Asked Questions

On This Page

General Questions

Import Requirements

Customs & Clearance

Compliance & Special Cases

Quick Resources

All Brazil Regulations How to Choose a Brazil Registration Holder Free Brazil Medical Device Classifier Brazil Medical Device Database Brazil Market Insights & Analytics Classification Game Pure Global Brazil Services

Key Dates & Milestones

PublishedDec 20, 2024

EffectiveJan 2, 2025

Grace Period30 days

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Note: This FAQ guide provides general information about regulatory requirements and should not be considered as legal advice. Regulations are subject to change. Always consult with qualified regulatory professionals for specific guidance.

Last updated: October 2025 | Based on RDC 925/2024 official documentation