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

RDC 751/2022 is ANVISA's comprehensive medical device regulation. It modernizes Brazil's framework with risk-based classification (I-IV) and streamlined pathways. Effective March 1, 2023, replacing RDC 185/2001.

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

Published September 15, 2022, effective March 1, 2023. Replaces RDC 185/2001 and consolidates multiple regulations into unified framework. Devices registered under old rules maintain validity until renewal.

What medical devices are covered under RDC 751/2022?

Covers all medical devices for human use including general devices, implants, software (SaMD), and accessories. Excludes IVDs (RDC 830/2023) and personalized devices.

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

Four classes by risk level. Class I (low) - bandages. Class II (medium) - ultrasound. Class III (high) - ventilators. Class IV (maximum) - pacemakers. Higher class = stricter requirements.

How do the 22 classification rules work?

22 rules categorized by device type: non-invasive (1-4), invasive (5-8), active (9-13), and special cases (14-22). Apply all relevant rules; highest classification prevails.

What's the difference between Notification and Marketing Authorization?

Notification (Class I-II) - 30-day simplified process, no expiration. Marketing Authorization (Class III-IV) - comprehensive review, 10-year validity, GMP required.

What documents are required for registration?

Notification needs basic forms and authorization letters. Marketing Authorization requires full technical dossier, GMP certificate, clinical evidence, and comprehensive documentation. All require Portuguese/Spanish/English.

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

Technical Dossier follows IMDRF structure with 6 chapters: Administrative info, device description, design/manufacturing, clinical evidence, labeling, and manufacturing sites. Class I-II maintain; Class III-IV submit.

What are the labeling requirements under RDC 751/2022?

Labels must include manufacturer info, registration holder, ANVISA number, batch/serial, dates, storage conditions, warnings. All in Portuguese. Equipment needs indelible label with traceability info.

Are Instructions for Use always required?

IFU required for Class III-IV, complex devices, reusables. May be exempted for simple Class I-II with self-evident use. Digital IFU allowed for professional devices with paper backup.

How are post-market changes handled?

Three categories: Required Approval (major changes, ANVISA approval needed), Immediate Implementation (medium changes, notify then implement), Non-Reportable (minor internal changes). Major changes need pre-approval.

What are the typical processing timelines?

Notification (Class I-II): 30 days automatic. Marketing Authorization (Class III-IV): 90-180 days. Changes: 30-120 days based on type. Actual times vary with submission quality.

How long is registration valid and how is it renewed?

Notification (Class I-II): No expiration, valid indefinitely. Marketing Authorization (Class III-IV): 10-year validity, renewal required 12 months before expiry. Both subject to post-market updates.

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

SaMD follows Rule 11: Class IV (death/irreversible deterioration), Class III (serious deterioration/surgery), Class II (monitoring), Class I (all other). Mobile apps are SaMD if meeting medical device definition.

How are devices with medicinal substances handled?

Automatically Class IV per Rule 14. Includes drug-eluting stents, antibiotic bone cements, antimicrobial dressings, devices with blood/plasma derivatives. Requires additional documentation for both device and medicinal components.

Is local representation required in Brazil?

Yes. Foreign manufacturers must have Brazilian registration holder as legal representative for all regulatory matters. Responsibilities include submissions, ANVISA liaison, GMP compliance, post-market surveillance, adverse events, technical documentation.

RDC 751/2022 FAQ - Updated October 2025

Brazil Medical Device Risk Classification & Registration Guide. Expert guidance by Pure Global regulatory specialists

ANVISA Regulation

Effective March 1, 2023

Replaces RDC 185/2001

340+ Pages

Official Document

Access the official document:Download RDC 751/2022 (English PDF)

Navigate Brazil's Regulatory Landscape with Pure Global

Your trusted partner for medical device registration in Brazil and 30+ global markets

Pure Global offers comprehensive regulatory consulting solutions for MedTech and IVD companies, combining local Brazilian expertise with advanced AI tools to streamline your market access under RDC 751/2022.

Brazil Registration

Expert ANVISA submission and local representation

Risk Classification

AI-powered classification analysis per RDC 751/2022

Technical Dossier

Complete documentation preparation and management

Learn more about Pure Global's Brazil regulatory services →

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

On This Page

General Questions

Risk Classification

Registration Process

Labeling & Compliance

Timelines & Validity

Special Considerations

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

PublishedAug 8, 2022

EffectiveMar 1, 2023

ReplacesRDC 185/2001

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Free consultation

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 751/2022 official documentation