Anvisa Opens Public Consultation on UDI Brazil Database Requirements

The National Health Surveillance Agency (Anvisa) published Public Consultation No. 1,313, of March 18, 2025, to receive contributions on the proposed Normative Instruction that establishes the requirements for the transmission and management of the database of the Unique Identification of Medical Devices (UDI Brazil) system.

The Public Consultation will be open for 60 days, allowing manufacturers, distributors, importers and other stakeholders in the medical device sector to submit suggestions and comments on the new regulations. The proposal aims to guarantee the standardization and traceability of medical devices in Brazil, promoting greater transparency, safety for patients and efficiency in regulatory processes.

The UDI Brazil regulations, as established by Collegiate Board Resolution (RDC) No. 591/2021, require manufacturers to transmit data from their medical devices to Anvisa's database, following clear guidelines to ensure regulatory compliance. The new Normative Instruction will define the criteria and technical requirements for implementing this process.

The active participation of the sector in the public consultation is essential to ensure that the regulations are practical, efficient and aligned with the needs of the market. Companies in the sector should assess the impacts of the proposed requirements and plan their strategies for adapting to future regulatory obligations.

Deadline for contributions: 60 days

Access the full text of the Public Consultation and take part!