What is RDC 751/2022?

RDC 751/2022 is ANVISA's regulation for medical device classification and registration in Brazil. Effective March 1, 2023, it establishes four risk classes (I-IV) and two registration pathways (notification/authorization).

What are the risk classifications under RDC 751/2022?

Four risk classes: Class I (low), Class II (medium), Class III (high), Class IV (maximum). Classes I-II use notification pathway. Classes III-IV require marketing authorization.

What is the difference between notification and marketing authorization?

Notification (Class I-II): Simplified 30-day process without pre-approval. Marketing Authorization (Class III-IV): Comprehensive technical review with 10-year validity requiring ANVISA approval.

How long is marketing authorization valid?

Marketing authorization is valid for 10 years from publication date. Renewal applications must be submitted 6-12 months before expiration for successive 10-year periods.

What are the labeling requirements under RDC 751/2022?

Labels require Portuguese language, ANVISA registration number, manufacturer details, batch/lot codes, and storage conditions. Instructions for use mandatory except for simple Class I-II devices.

RDC 751/2022 FAQ - Updated September 2025

Brazil Medical Device Risk Classification & Registration Guide

ANVISA Regulation

Effective March 1, 2023

Replaces RDC 185/2001

340+ Pages

Official Document Available

Access the official English translation of RDC 751/2022 directly from ANVISA:Download RDC 751/2022 (English PDF)

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Risk Classes

4 Classes

I (Low) to IV (Maximum)

Notification

Class I & II

30 days processing

Authorization

Class III & IV

10 year validity

Classification Rules

22 Rules

Comprehensive criteria

Frequently Asked Questions

General Questions

Risk Classification

Registration Process

Labeling & Compliance

Timelines & Validity

Special Considerations

Quick Resources

Official RDC 751/2022 (English)Try Our AI Classifier Free Brazil Medical Device Database Pure Global Brazil Services

Important Dates

PublishedSep 15, 2022

EffectiveMar 1, 2023

ReplacesRDC 185/2001

Registration Pathways

Class I

Notification

Class II

Notification

Class III

Authorization

Class IV

Authorization

Janaina dos Santos de Miranda

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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 registration in Brazil.

Last updated: October 1, 2025 | Based on RDC 751/2022 official English translation

RDC 751/2022 FAQ - Updated September 2025

Official Document Available

Frequently Asked Questions

General Questions

What is RDC 751/2022 and why is it important?

When did RDC 751/2022 come into effect and what did it replace?

What medical devices are covered under RDC 751/2022?

Risk Classification

What are the four risk classes and how are they determined?

How do the 22 classification rules work?

Registration Process

What's the difference between Notification and Marketing Authorization?

What documents are required for registration?

What is the Technical Dossier structure under RDC 751/2022?

Labeling & Compliance

What are the labeling requirements under RDC 751/2022?

Are Instructions for Use always required?

How are post-market changes handled?

Timelines & Validity

What are the typical processing timelines?

How long is registration valid and how is it renewed?

Special Considerations

How is Software as a Medical Device (SaMD) classified?

How are devices with medicinal substances handled?

Is local representation required in Brazil?

Janaina dos Santos de Miranda