Anvisa Launches Public Consultation on UDI Data Requirements for Medical Devices

Brazil’s National Health Surveillance Agency (Anvisa) has opened Public Consultation No. 1,313, seeking public input on a proposed Normative Instruction that defines how companies must transmit and manage data under the Unique Device Identification (UDI) system for medical devices. Contributions can be submitted until May 26, 2025.

Background: What Is RDC No. 591/2021?

The consultation stems from Collegiate Board Resolution (RDC) No. 591, issued in December 2021, which introduced Brazil’s UDI framework for medical devices. The regulation aims to enhance the traceability, safety, and post-market surveillance of medical products by requiring that each device be assigned a unique identifier.

RDC 591/2021 mandated that UDI data must be transmitted to a centralized Anvisa database, but the obligation would only begin once Anvisa officially confirmed that its system was ready to receive such data.

Why This Public Consultation?

Public Consultation No. 1,313 fulfills that requirement. It:

• Announces that Anvisa’s UDI database (SIUD) is now operational and capable of receiving UDI data.

• Presents a draft Normative Instruction detailing the technical and procedural requirements for transmitting this data.

• Invites stakeholders—such as manufacturers, importers, and healthcare entities—to review and comment on the proposed framework before it is finalized.

Key Elements of the Draft Normative 

The Normative Instruction establishes:

• Two methods for UDI data transmission: individual or bulk submission.

• Company responsibilities, including the option to authorize third-party users to submit data on their behalf.

• Rules for data modification, publication, and device discontinuation.

• A timeline for mandatory compliance, based on the risk classification of each medical device as outlined in RDC 591/2021.

Devices already on the market may have their UDI data submitted voluntarily, even before mandatory deadlines apply.

How to Participate

Comments can be submitted via Anvisa Portal: Contribution Form

Submissions are public and will be available for review after the consultation closes.  Once the consultation period ends, Anvisa will analyze the input and publish the final version of the Normative Instruction, which is expected to take effect on July 1, 2025. The agency also plans to release detailed implementation guides and a user manual for the SIUD system.

This marks a significant step toward strengthening Brazil’s regulatory infrastructure for medical devices and aligning with international best practices for UDI implementation.