ANVISA Normative Instruction 426/2026 on UDI Database

Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) published Normative Instruction No. 426 of February 13, 2026, establishing requirements for the transmission and management of the Unique Identification of Medical Devices (UDI) database in compliance with RDC No. 591/2021.

The regulation was published in the Official Gazette of the Union on February 18, 2026 (Edition 32, Section 1, Page 209) and enters into force on March 1, 2026.

The Instruction operationalizes Brazil’s UDI System by defining how data must be transmitted, corrected, maintained, and governed within the national database.

Scope and Legal Basis

Normative Instruction 426/2026 was adopted by ANVISA’s Collegiate Board under:

• Law No. 9,782/1999

• Internal Regulations approved by RDC No. 585/2021

• Article 15, §3 of RDC No. 591/2021

It applies to all medical devices subject to RDC 591/2021 or any regulation that may replace it.

Key Provisions of Normative Instruction 426/2026

1. Creation and Governance of SIUD

The regulation formally defines the Unique Device Identification System (SIUD) as Brazil’s electronic UDI database.

Key definitions include:

• UDI data: dataset characterizing a medical device model linked to its UDI-DI

• Sanitary regularization: ANVISA authorization (registration or notification)

• Availability in the Brazilian market: commercialization by the registration holder

2. Initial UDI Data Transmission Requirements

Before a medical device is made available in Brazil:

• UDI data must be transmitted to SIUD

• Data must match ANVISA-approved product information

• Only the UDI-DI component must be submitted

However, companies must maintain the UDI-PI component in their Quality Management System in accordance with RDC No. 665/2022 to ensure full traceability.

Each UDI dataset must correspond to one single UDI-DI per device model.

3. Transmission Methods

UDI data may be transmitted:

• Individually via electronic form (manual interface), or

• In bulk, via structured file upload or machine-to-machine communication

Companies opting for bulk transmission must implement appropriate technical solutions in accordance with ANVISA’s implementation guide.

Only the registration holder — or an authorized third party — may transmit UDI data.

4. Publication and Corrections

• UDI data becomes publicly available on ANVISA’s portal on the informed publication date.

• Corrections are permitted within 60 calendar days after publication.

• After the grace period, only changes not requiring a new UDI-DI are allowed.

If a change requires issuance of a new UDI-DI, replacement must occur within 30 calendar days from publication of the change in the Official Gazette.

The publication date cannot be modified once reached.

5. Ownership Transfers and Discontinuation

In cases of transfer of sanitary regularization ownership:

• Formal procedures under RDC No. 903/2024 must be completed first.

• The successor company must transmit UDI-DI data within 30 days after publication of the transfer act.

For discontinuation or cancellation:

The registration holder must inactivate the UDI-DI in SIUD within 30 days if:

• The product is withdrawn from the Brazilian market

• The authorization expires

• The registration is canceled

Failure to comply constitutes a sanitary infraction under Law No. 6,437/1977.

6. Third-Party User Authorization

Registration holders may authorize third-party users within SIUD to transmit UDI data.

However:

• Responsibility remains with the registration holder

• The holder must define the scope of authorized products

Deadlines for Mandatory Transmission

According to Article 11, compulsory UDI transmission deadlines follow the risk-class schedule established in Article 15 of RDC No. 591/2021:

• Class IV: July 10, 2025

• Class III: January 10, 2026

• Class II: January 10, 2027

• Class I: January 10, 2028

Until the applicable mandatory deadline is reached, companies may submit UDI data voluntarily.

Additionally:

• Devices already marketed and in use may be voluntarily registered at any time.

• ANVISA may temporarily suspend transmission for specific device types to preserve SIUD system functionality.

Why This Update Matters

Normative Instruction 426/2026 transforms Brazil’s UDI framework from a legal obligation into an operational digital compliance system.

By formalizing transmission rules, correction timelines, governance procedures, and enforcement mechanisms, ANVISA strengthens:

• Device traceability

• Post-market surveillance

• Recall management

• Regulatory transparency

Medical device companies operating in Brazil must now ensure not only UDI labeling compliance but also continuous database governance within SIUD.

External References

For full regulatory text, consult:

• ANVISA Official Website (Normative Instruction No. 426/2026)

Internal References

Learn more about:

• ANVISA Brazil Medical Device Registration

• Simplified Pricing for Medical Device Registration

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