What is RDC 848/2024 and why is it important?

RDC 848/2024 is ANVISA's regulation for medical device regularization. Published November 29, 2024, effective December 2, 2024. Establishes compliance requirements for all medical device companies in Brazil.

Who must comply with RDC 848/2024?

All manufacturers, importers, and registration holders of medical devices in Brazil. Applies to all risk classes (I-IV) regardless of registration pathway.

When did RDC 848/2024 come into effect?

Published November 29, 2024. Effective December 2, 2024. No transition period - immediate compliance required for all regulated entities.

What is the regularization process under RDC 848/2024?

Regularization ensures devices meet all regulatory requirements. Includes valid registration, QMS certification, technical documentation, and continuous monitoring.

What technical documentation is required?

Complete technical dossier per device classification. Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR) required.

What are the Quality Management System requirements?

QMS per ISO 13485 and RDC 665/2022 required. Includes management responsibility, resource management, product realization, and measurement systems.

What are the vigilance reporting requirements?

Mandatory reporting of adverse events and field actions. Death/serious injury: 10 days. Other events: 30 days. Field actions: immediate notification.

What are the traceability requirements?

Complete traceability from raw materials to end user required. Unique Device Identification (UDI) for Class III-IV. Batch/lot tracking for all classes.

What are the penalties for non-compliance?

Penalties range from warnings to R$1.5 million fines. Includes product seizure, manufacturing suspension, and registration cancellation. Criminal prosecution possible for serious violations.

How does ANVISA conduct inspections?

ANVISA conducts routine, follow-up, and for-cause inspections. Can be announced or unannounced. Full documentation review and facility assessment.

What are the key steps for RDC 848/2024 compliance?

Gap assessment, remediation plan, system implementation, documentation update, training, and validation. Timeline: 3-6 months for full compliance.

What are the best practices for maintaining compliance?

Regular internal audits, continuous training, proactive vigilance, robust change control, and management review. Establish compliance culture throughout organization.

RDC 848/2024 FAQ - Updated October 2025

Brazil Medical Device Regulatory Compliance. Expert guidance by Pure Global regulatory specialists

ANVISA Compliance Regulation

Effective December 2, 2024

Quality Management

Post-Market Surveillance

Official Document

Access the official document:Download RDC 848/2024 (Portuguese)

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Scope

All Classes

Classes I-IV

QMS

Required

Per RDC 665/2022

Documentation

Mandatory

Technical dossier

Vigilance

Active

Continuous monitoring

Frequently Asked Questions

On This Page

General Questions

Regularization Requirements

Vigilance & Post-Market Surveillance

Compliance & Penalties

Implementation Guidance

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

PublishedNov 2024

EffectiveDec 2, 2024

DJ Fang

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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 848/2024 official documentation