Brazil’s UDI Update RDC 591/2021

By Luiz Levy 

Background on UDI

Brazil’s implementation of the Unique Device Identification (UDI) system began with the publication of RDC 591/2021, which came into force in early 2022. This regulation established the foundational framework for UDI assignment -requiring manufacturers (or their representative Brazil Registration Holder (BRH)) to generate UDI-DI and UDI-PI codes, affix them to device labels, submit product‑related information, and report adverse events and technical complaints using the UDI identifiers, and include this in ANVISA’s future UDI database.

Since 2022, ANVISA has continued to evolve the system through additional regulatory actions, most notably RDC 884/2024, which updated and extended UDI implementation deadlines across device risk classes and amended provisions of RDC 591/2021 to improve clarity and regulatory impact.

Additionally, on March 20, 2025, ANVISA opened a public consultation (Public Consultation 13/2025) regarding the future UDI database, known as SIUD, and the associated data transmission requirements.

Current status of requirements

RDC 884/2024 requires the UDI carrier to be on the device label and all levels of packaging, per highest risk devices first. 

For devices that require direct marketing, the deadline for each risk classification is an additional two years.

Deadline to submit UDI information to SIUD and include UDI-DI and UDI-Pi on post-marketing submissions

The normative instruction is yet to be published. However, as reported by ANVISA, UDI is one of the priorities in the ANVISA Regulatory Agenda for 2026-2027.

Concluding remarks

As described, UDI implementation in Brazil continues to advance, and the requirement to apply the UDI carrier to device labels and all levels of packaging, except shipping containers, is already mandatory for Class IV and Class III medical devices. This will become compulsory for Class II device labels and packaging in 2027, followed by 2028 for Class I devices. Announcement of the SIUD is expected in 2026.

Given these accelerating regulatory timelines, manufacturers comply with RDC 591/2021, as amended, thereby meeting all applicable UDI requirements and preparing their medical device portfolios for upcoming obligations. Note that the authorized UDI-issuing organizations in Brazil align with the U.S. FDA and Australia TGA. 

UDI may be perceived as another regulatory requirement; however, it is a critical regulatory element that will increase device traceability to facilitate continuous device safety and effectiveness.

Emergo by UL experts will host a new webinar featuring the latest regulatory updates for Brazil, where UDI implementation is a key highlight. Please watch your email for more information.