Pure Global

RDC 848/2024 FAQ - Updated September 2025

Brazil Medical Device Regularization & Compliance Guide

ANVISA Compliance
Effective Dec 2, 2024
Quality Systems
Regularization
Ensure Compliance with Pure Global's Expertise
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Pure Global offers end-to-end regulatory consulting solutions, combining 20+ years of ANVISA expertise with advanced AI tools to ensure your devices meet all RDC 848/2024 compliance requirements.

Regularization Support

Complete registration and compliance management

QMS Implementation

ISO 13485 and RDC 665/2022 alignment

Local Representation

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Scope
All Devices

Classes I-IV

Effective Date
Dec 2, 2024

In force now

Key Focus
Compliance

QMS & Vigilance

Penalties
R$1.5M

Maximum fine

Frequently Asked Questions

General Questions

Regularization Requirements

Vigilance & Post-Market Surveillance

Compliance & Penalties

Implementation Guidance

Quick Resources
Official RDC 848/2024 (Portuguese)RDC 751/2022 FAQRDC 830/2023 FAQTry Our AI ClassifierFree Brazil Medical Device DatabasePure Global Brazil Services
Important Dates
PublishedNov 29, 2024
EffectiveDec 2, 2024
ComplianceImmediate
Compliance Areas
Registration
Required
QMS
ISO 13485
Vigilance
Mandatory
Traceability
All Classes
Janaina dos Santos de Miranda

Janaina dos Santos de Miranda

🇧🇷 Brazil Regulatory Expert

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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 compliance in Brazil.

Last updated: October 1, 2025 | Based on RDC 848/2024 official publication