Brazil’s ANVISA Advances UDI Implementation

By Luiz Levy and Evangeline Loh

On February 18, 2026, ANVISA issued Normative Instruction (IN) No. 426/2026, establishing the technical and operational requirements for the submission and management of UDI data within the ANVISA UDI database, SIUD.

The regulation becomes effective March 1, 2026. Here we discuss the key provisions.

Key provisions of IN 426/2026

The IN sets requirements related to the use of SIUD: submission within SIUD, cases that require revision to the SIUD data (correction to data transmission, changes that require a new UDI-DI, UDI‑DI submission for devices that have undergone a registration ownership transfer, requirement associated with UDI inactivation), and deadlines based on device risk class.

Transmission requirements for SIUD

The Brazilian Registration Holder (BRH) or manufacturer based in Brazil is responsible for UDI submission. However, the regulation allows the company to authorize third‑party users.  Medical devices within the scope of Resolution No. 591/2021, must have their UDI data transmitted to SIUD before being made available on the Brazilian market. 

There are flexible submission pathways, enabling data transmission via online forms on SIUD or in bulk through structured files or using a machine‑to‑machine (M2M) model. Based on the ANVISA UDI guidance document rev 0.8, the file to be transmitted follows the FHIR/HL7 standard, and XML and JSON formats are accepted.

The UDI-DI data will be mandatory in SIUD. The production identifier (UDI‑PI) must be kept internally for traceability purposes and is not submitted in SIUD.

The UDI data transmitted to SIUD will be published (when the publication date specified in the filing is reached), and will be publicly available.

Implementation timeline by device risk class

With the publication of the IN, the deadlines for UDI data transmission to the SIUD database are defined according to the device risk classification.

The deadlines are as follows: 

Class IV: September 1, 2029

Class III: March 1, 2030

Class II: March 1, 2031

Class I: March 1, 2032

Corrections to SIUD

The IN permits corrections to UDI data during a 60-day grace period, counted from the date the UDI data is published. There is a deadline of 30 days for updates in the SIUD (counted from the date the change is published in the Official Gazette) when there is a change that requires the issuance of a new UDI-DI. Similarly, if there is a cancellation and ownership transfer of the registration, there is a 30-day deadline for the submission of the UDI-DI in SIUD.

Last, there are deadlines related to UDI-DI inactivation.

Concluding remarks

This long‑awaited IN is a decisive step toward strengthening device traceability in Brazil, providing the operational framework for the  UDI system and positioning Brazil in alignment with international regulatory frameworks such as FDA GUDID and EU EUDAMED, supporting greater transparency, interoperability and post‑market surveillance.

For BRHs and manufacturers, the regulation marks the beginning of a critical transition period. While they are over three years for the highest risk devices, success will depend on early planning, alignment between the stakeholders to confirm UDI-DI is submitted prior to the device being made available and when applicable, is updated in compliance with the regulation’s requirements. 

Failure to comply with these provisions subject the BRH (and manufacturer) to sanitary infractions with penalties dictated by Law No. 6,437/1977. Manufacturers must engage BRHs who are knowledgeable about the market and experts in the regulatory requirements.