ANVISA Publishes More UDI Guidance

By Luiz Levy and Evangeline Loh

The National Health Surveillance Agency in Brazil, ANVISA, published further unique device identifier (UDI) guidance: RDC 591/2021. Some of Its requirements became mandatory on July 10, 2025.

The background on Unique Device Identifier (UDI) requirements in Brazil can be described by the following: RDC 591/2021, RDC 884/2024, and Public Consultation 1.313/2025.  Class IV medical devices must comply with the UDI labeling requirements as of July 10. This means the UDI carrier must be applied to the device label and all levels of packaging, except shipping containers. 

In addition, the pilot testing of the ANVISA UDI database, Sistema de Identificação Única de Dispositivos Médicos, SIUD, was completed at the end of May, and it was announced that an instrução normativa (normative instruction) would be released with the deadlines for SIUD. 

Recent official notice

ANVISA published (July 10, 2025) Official Notice Circular 2/2025/SEI/GGTPS/DIRE3/ANVISA to provide guidance on the UDI labeling requirements, as well as delineate the background on UDI. The official circular reminds readers of the importance of UDI. The requirements in Brazil follow guidance from the International Medical Device Regulators Forum (IMDRF). The notice reiterates the deadlines for UDI markings on labeling, as well as deadlines for UDI on the device itself and reusable medical devices. 

ANVISA also summarized the Launch of the UDI System and GGTPS Updates event, which was held on June 30. The electronic address for the SIUD instruction document library was announced.

Items 13-24 guidance on UDI code and representation on labeling

Items 13-24 guide the UDI Code expectations on labeling. It outlines the legislative requirements: UDI-DI, UDI-PI, automatic identification and data capture (AIDC), and human-readable interpretation (HRI). In addition, there are two examples from the labeling of medical devices that are marketed. Notably, the UDI symbol is only required if more than one form of AIDC is included.  

UDI enhances device traceability and more

The normative Instruction for SIUD is close to publication. The expectation based on the latest updates is that this normative Instruction will come into force in September 2025 (item 37). There will be transition timelines before the official deadlines become effective, phased in based on highest to lowest risk. 

UDI may be perceived as another regulatory requirement; however, it is a critical regulatory element that enhances device traceability, facilitating continuous monitoring of device safety and effectiveness.