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

RDC 830/2023 is ANVISA's IVD-specific regulation. Effective June 1, 2024, replacing RDC 36/2015. Aligns with IMDRF standards. Covers reagents, analyzers, and companion diagnostics.

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

Published December 11, 2023, effective June 1, 2024. Replaces RDC 36/2015 and consolidates IVD requirements. Products registered before June 2024 remain valid until renewal.

What products are covered by RDC 830/2023?

Covers all IVD devices - reagents, calibrators, analyzers, self-tests, companion diagnostics, and point-of-care tests. Excludes general lab equipment.

How does the IVD risk classification system work?

Four classes by health impact. Class I - specimen containers. Class II - pregnancy tests. Class III - glucose monitors. Class IV - HIV tests. Higher risk = stricter controls.

What criteria determine IVD risk classification?

Classification based on seven factors: intended use, user expertise, diagnostic importance, result impact, target population, disease severity, and public health impact.

How are self-testing IVD devices classified?

Self-tests classified one level higher. Minimum Class II. HIV self-tests always Class IV. Glucose Class III. Pregnancy Class II.

What is the difference between Notification and Marketing Authorization?

Notification (Class I-II): Simplified process, 5-year validity, immediate approval, no pre-review. Marketing Authorization (Class III-IV): Comprehensive review, 10-year validity, 90-365 days timeline.

What must be included in the technical dossier?

Technical dossier follows IMDRF STED format with 6 chapters: Regional Administrative, Submission Context, Non-Clinical Evidence, Clinical Evidence, Labeling, and QMS documentation.

What are the typical registration timelines?

Class I-II Notification: Immediate approval. Class III Authorization: 120-180 days. Class IV Authorization: 180-365 days. Pure Global reduces timelines by 30%.

What are the language requirements for IVD labeling?

All labeling must be in Brazilian Portuguese. Minimum font 1.0mm (1.2mm for self-tests). ISO symbols accepted. Dual language allowed. e-IFU permitted for professional devices.

What information must appear on IVD labels?

23 required elements including product info (name, registration, lot, expiry), company details (manufacturer, registration holder), storage conditions, and safety warnings.

What are the vigilance reporting requirements?

Serious adverse events: 10-30 days. Recalls: 48 hours. Field Safety Notices: 5 days. Periodic reports: Annual (Class III-IV), biennial (Class I-II).

What are the renewal requirements?

Notification: 5-year validity, submit 12 months before expiry, automatic renewal. Authorization: 10-year validity, full dossier update, complete ANVISA review required.

How are companion diagnostics regulated?

Automatic Class IV classification. Requires co-development with therapeutic, Brazilian population bridging studies, joint pharmaceutical review, and annual concordance studies.

What are the requirements for AI-based IVD software?

AI/ML IVDs require algorithm transparency, Brazilian population in training data, continuous learning protocols, bias assessment, cybersecurity measures, and real-world performance monitoring.

What are the transition provisions from RDC 36/2015?

Products registered before June 1, 2024 remain valid until expiration. New applications must comply with RDC 830/2023. Pending applications have withdrawal/resubmit option within 60 days.

RDC 830/2023 FAQ - Updated October 2025

Brazil Brazil In Vitro Diagnostic (IVD) Medical Device Regulation Guide. Expert guidance by Pure Global regulatory specialists

ANVISA IVD Regulation

Effective June 1, 2024

Replaces RDC 36/2015

141 Articles

Official Document

Access the official document:Download RDC 830/2023 (English PDF)

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IVD Classification

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Clinical Evidence

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Companion Diagnostics

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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

On This Page

General Questions

Risk Classification

Registration Pathways

Labeling Requirements

Post-Market Requirements

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

PublishedDec 11, 2023

EffectiveJun 1, 2024

ReplacesRDC 36/2015

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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 830/2023 official documentation