What is RDC 830/2023?

RDC 830/2023 is ANVISA's regulation for IVD medical devices. Effective June 1, 2024, it establishes four risk classes and modernized registration pathways replacing RDC 36/2015.

How are IVD devices classified under RDC 830/2023?

Four classes by health risk: Class I (low), Class II (low-moderate), Class III (moderate), Class IV (high). Based on intended use, user expertise, and diagnostic impact.

What are the registration pathways for IVD devices?

Two pathways: Notification (Class I-II) - 5-year validity, no pre-review. Marketing Authorization (Class III-IV) - 10-year validity, clinical evidence required.

What are the requirements for self-testing IVD devices?

Self-tests classified one class higher than professional versions. Minimum Class II. Require pictorial instructions, larger fonts, and medical consultation warnings.

How are companion diagnostics regulated?

Companion diagnostics automatically Class IV. Require co-development with therapeutic, Brazilian population bridging studies, and joint pharmaceutical review.

RDC 830/2023 FAQ - Updated September 2025

Brazil In Vitro Diagnostic (IVD) Medical Device Regulation Guide

ANVISA IVD Regulation

Effective June 1, 2024

Replaces RDC 36/2015

141 Articles

Official Document Available

Access the official English translation of RDC 830/2023 directly from ANVISA:Download RDC 830/2023 (English PDF)

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Risk Classes

4 Classes

I (Low) to IV (High)

Notification

Class I & II

5 year validity

Authorization

Class III & IV

10 year validity

Self-Testing

Min. Class II

Special requirements

Frequently Asked Questions

General Questions

Risk Classification

Registration Pathways

Labeling Requirements

Post-Market Requirements

Special Considerations

Quick Links

Official RDC 830/2023 (English)Try Our AI Classifier Free Brazil Medical Device Database Pure Global Brazil Services

Important Dates

PublishedDec 11, 2023

EffectiveJun 1, 2024

ReplacesRDC 36/2015

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 IVD medical device registration in Brazil.

Last updated: October 1, 2025 | Based on RDC 830/2023 official English translation

RDC 830/2023 FAQ - Updated September 2025

Official Document Available

Frequently Asked Questions

General Questions

What is RDC 830/2023 and why is it important?

When did RDC 830/2023 come into effect and what did it replace?

What products are covered by RDC 830/2023?

Risk Classification

How does the IVD risk classification system work?

What criteria determine IVD risk classification?

How are self-testing IVD devices classified?

Registration Pathways

What is the difference between Notification and Marketing Authorization?

What must be included in the technical dossier?

What are the typical registration timelines?

Labeling Requirements

What are the language requirements for IVD labeling?

What information must appear on IVD labels?

Post-Market Requirements

What are the vigilance reporting requirements?

What are the renewal requirements?

Special Considerations

How are companion diagnostics regulated?

What are the requirements for AI-based IVD software?

What are the transition provisions from RDC 36/2015?

Janaina dos Santos de Miranda