What is RDC 591/2021 and what does it establish?

RDC 591/2021 establishes Brazil's UDI system for medical devices, requiring unique identifiers, barcoded labels, and GUDID database registration for enhanced traceability.

Which medical devices are covered by the UDI requirements?

All ANVISA-regulated medical devices (Classes I-IV) including implantables, reusables, IVDs, and software medical devices must comply with UDI requirements.

What are the key objectives of Brazil's UDI system?

Brazil's UDI system enhances patient safety, improves traceability, facilitates recalls, strengthens surveillance, and standardizes device identification across healthcare.

What are the components of a UDI in Brazil?

Brazil's UDI has two parts: UDI-DI (device model identifier) and UDI-PI (production information like lot, serial, expiration dates) in human and machine-readable formats.

What barcode standards are accepted for UDI in Brazil?

Brazil accepts GS1, HIBCC, and ICCBBA standards for UDI barcodes, including linear (GS1-128) and 2D formats (DataMatrix, QR codes).

How should the UDI be displayed on device labels?

UDI must appear in human-readable text (preceded by 'UDI') and machine-readable barcode format, permanently affixed and prominently displayed on labels.

What is the implementation timeline for UDI requirements?

UDI implementation phases: Class III/IV implantables (2022), all Class III/IV (2023), Class II implantables (2024), all Class II (2025), Class I (2026).

Are there different timelines for direct marking requirements?

Direct marking timelines: Class III/IV reusable devices by December 2025, Class I/II reusable devices by December 2027 for permanent UDI marking.

What about devices already on the market?

Pre-compliance date devices can remain without UDI until expiration, but all new production after compliance dates must include UDI labeling.

What is Brazil's GUDID and what information must be submitted?

GUDID is ANVISA's UDI database requiring device identification, manufacturer details, registration numbers, risk class, GMDN codes, and packaging information submission.

How and when should GUDID data be submitted?

GUDID submission required before market placement via ANVISA's portal, with updates within 30 days of changes, supporting manual and bulk XML uploads.

What are the data quality requirements for GUDID?

GUDID requires complete, accurate Portuguese data matching ANVISA records, with valid GMDN codes and documentation supporting all submissions.

How does UDI apply to different levels of packaging?

Each distributed packaging level needs its own UDI, from unit packages to cases, with unique UDI-DI and appropriate UDI-PI for each level.

What are the requirements for UDI on small devices?

Small devices may use abbreviated UDI or higher-level packaging placement, prioritizing UDI-DI, with RFID alternatives possible for tiny implantables.

Are there special considerations for sterile device packaging?

Sterile devices need UDI on all sterility-maintaining packages, including opaque barriers, with distinct UDI-DIs for sterile versus non-sterile versions.

What steps should manufacturers take to implement UDI?

Implement UDI by selecting issuing agency, generating codes, updating labels/systems, preparing GUDID submissions, training staff, and coordinating supply chain.

How can distributors and importers prepare for UDI?

Distributors need UDI-capable systems and training; importers must ensure foreign manufacturer compliance with Brazil's UDI requirements and timelines.

What are common UDI implementation challenges?

UDI challenges include label redesign, IT integration, portfolio management, global coordination, training needs, data accuracy, and transition inventory management.

What devices are exempt from UDI requirements?

UDI exemptions include non-implantable custom devices, clinical trial devices, manufacturer components, and bulk IVD reagents with specific conditions.

How are configurable devices and systems handled?

Configurable devices need base UDI with separate UDI-DIs for distinct configurations; separately-sold system components require individual UDIs.

What about combination products and procedure packs?

Combination products need UDI for device components; procedure packs require pack-level UDI linked to individual component UDIs in GUDID.

What are ongoing UDI maintenance requirements?

Maintain UDI records for device lifetime +5 years, update GUDID within 30 days, ensure documentation consistency, and include UDI in surveillance reports.

How is UDI used in adverse event reporting?

Include UDI in NOTIVISA adverse event reports for better incident tracking, faster problem identification, and targeted recall management.

What are the penalties for non-compliance with UDI requirements?

UDI non-compliance penalties include registration suspension, sales prohibition, recalls, monetary fines, and increased ANVISA inspection frequency.

RDC 591/2021 FAQ - Updated October 2025

Brazil Medical Device UDI System. Expert guidance by Pure Global regulatory specialists

ANVISA UDI Regulation

Phased Implementation

GUDID Database

Device Traceability

Official Document

Access the official document:Download RDC 591/2021 (Portuguese)

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GUDID Submission

Expert database registration and data management

Barcode Standards

GS1, HIBCC, and ICCBBA compliance guidance

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UDI Components

2 Parts

UDI-DI + UDI-PI

Standards

GS1/HIBCC

International barcode formats

Database

GUDID

ANVISA device database

Timeline

2022-2026

Phased by risk class

Frequently Asked Questions

On This Page

Overview & Scope

UDI Structure & Components

Implementation Timeline

GUDID Database Requirements

Labeling & Packaging Requirements

Compliance Strategies

Exceptions & Special Cases

Post-Market Obligations

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

Class III/IV ImplantableDec 2022

All Class III/IVDec 2023

All Class IIDec 2025

Class IDec 2026

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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 591/2021 official documentation