Pure Global

RDC 925/2024 FAQ - Updated September 2025

Brazil Medical Device Sanitary Control & Import Guide

ANVISA Import Control
Effective Jan 2, 2025
Customs Requirements
Sanitary Authorization
Streamline Your Brazil Imports with Pure Global
Your trusted partner for medical device importation and sanitary control in Brazil

Pure Global provides end-to-end import facilitation services, combining 20+ years of ANVISA expertise with local representation to ensure smooth customs clearance and regulatory compliance for your medical devices.

Import Management

Complete import license and customs support

Local Representation

Brazilian registration holder services

Compliance Support

Documentation and sanitary authorization

Learn more about Pure Global's Brazil import services →
Scope
All Imports

Medical devices

Effective Date
Jan 2, 2025

In force soon

Key Process
SISCOMEX

Import system

Processing
5-10 days

Typical timeline

Frequently Asked Questions

General Questions

Import Requirements

Customs & Clearance

Compliance & Special Cases

Quick Resources
Official RDC 925/2024 (Portuguese)RDC 751/2022 Classification FAQRDC 848/2024 Compliance FAQTry Our AI ClassifierFree Brazil Medical Device DatabasePure Global Brazil Services
Important Dates
PublishedDec 20, 2024
EffectiveJan 2, 2025
Grace Period30 days
Import Process
Registration
Required
License
SISCOMEX
Inspection
Risk-based
Timeline
5-10 days
Janaina dos Santos de Miranda

Janaina dos Santos de Miranda

🇧🇷 Brazil Regulatory Expert

Need help with your Brazil registration?

Contact Pure Global Brazil Team
Free consultation

Disclaimer: This FAQ is for informational purposes only and does not constitute legal or regulatory advice. Regulations are subject to change. Always consult with qualified regulatory professionals or Pure Global experts for specific guidance on your medical device importation to Brazil.

Last updated: October 1, 2025 | Based on RDC 925/2024 official publication