Current State of UDI in Brazil: Review of RDC 591/2021 and RDC 884/2024

By Luiz Levy, Lilian Pinheiro and Evangeline Loh

The Normative Instruction to announce the ANVISA UDI database, SIUD, is expected soon

Background on RDC 591/2021

The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency responsible for the supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices. Recently, ANVISA enacted RDC 591/2021, which legislated the Unique Device Identifier (UDI) requirements for medical devices and IVDs in Brazil. The rules to facilitate traceability and unique identification are harmonized with international practices and established requirements for the UDI system.

Similar to global expectations, the UDI-DI (Device Identifier) is a fixed portion of the UDI that identifies the specific version or model of a device, while the UDI-PI (Production Identifier) includes variable information, lot or batch number, serial number and expiration date.

The resolution became effective in early 2022 with a three-year transition.  

Background on RDC 884/2024

In July 2024, RDC 884/2024 extended the UDI timelines (generally by one year) based on risk class, extending the deadlines to the following:

• Class IV medical devices - July 10, 2025
• Class III medical devices - January 10, 2026
• Class II medical devices - January 10, 2027
• Class I medical devices (no change) - January 10, 2028
• Reusable devices that require UDI direct marking – two years after the relevant risk deadline

Note that for Class IV medical devices, the deadline to apply a UDI carrier to the device label and all upper levels of packaging (except shipping container, which is not required)  is July 10, 2025.

Recent ANVISA consultation

ANVISA published (March 20, 2025) a public consultation (Public Consult 13/2025) on the future UDI database and the transmission requirements. It has already been announced that the ANVISA UDI database will be referred to as Sistema de Identificação Única de Dispositivos Médicos (SIUD).

Use of SIUD will be officially announced in a specific Instrução Normativa (Normative Instruction). Only after the Normative Instruction publication will transition timelines and official deadlines become effective.

Concluding remarks

We at Emergo by UL will continue to monitor regulatory developments in Brazil for news about this Normative Instruction. At Hospitalar (May 2025), ANVISA announced that this legislation is close to publication. While UDI may be perceived as yet another regulatory requirement, it is a critical regulatory component designed to increase device traceability, and as a result, facilitate continuous device safety and effectiveness.