The document highlights the features of the Unique Device Identification system that are already available.
Anvisa has recently published the preliminary version of the operations manual for the UDI (Unique Device Identification) database—an international system designed to identify and track medical devices marketed in Brazil. This initiative represents a significant step forward for patient safety and the regulatory management of these products.
What is the UDI database?
Anvisa’s UDI database is part of the implementation of the international Unique Device Identification standard, in accordance with the guidelines of the International Medical Device Regulators Forum (IMDRF). The objective is to enable precise and standardized identification of each medical device, facilitating its traceability throughout its entire life cycle in the market.
RDC 591/2021: regulatory milestone for UDI in Brazil
The integration of the UDI system into Brazilian regulation was established through
Resolution of the Collegiate Board (RDC) 591/2021, published on December 21, 2021. The regulation required Anvisa to develop a national database to store and provide information related to the UDI of all medical devices registered in the country.
This development has been classified as a strategic priority and is part of Anvisa’s 2024–2027 Strategic Plan, identified as Strategic Project 02.
Anvisa Publishes Preliminary Guidelines Manual for the UDI System (Siud)
With the system nearing completion, Anvisa has published the preliminary version of the User Manual for the Unique Device Identification System (Siud). This document provides practical guidance for the regulated sector on the platform features that are already available.
Important: the manual does not include instructions for features still under development.
When will the UDI database be available?
Anvisa’s UDI database has not yet been officially published. Its release is conditional on the entry into force of the Normative Instruction that will be approved following Public Consultation (PC) No. 1,313/2025. The system will become available simultaneously with this publication.
Deadlines for submitting UDI information
RDC 591/2021 established the following deadlines for the mandatory submission of UDI information, counted from the effective date of the new Normative Instruction:
- Class IV: 3.5 years
- Class III: 4 years
- Class II: 5 years
- Class I: 6 years
These deadlines provide companies in the sector with the necessary time to properly prepare for regulatory compliance.
Public Consultation open until May 26
Public Consultation No. 1,313/2025 remains open for contributions from both the public and the regulated sector until May 26. Participation is essential to improve the requirements and ensure that the UDI database meets the needs of both the market and health surveillance.
To contribute, access the official links:
Conclusion
The implementation of Anvisa’s UDI database represents a major regulatory milestone, aligning Brazil more closely with international standards for the traceability of medical devices. This is a key moment for companies to prepare and adapt, and active participation in the public consultation is essential to help build a robust, secure, and functional system.