UDI and SIUD: the new milestone of medical device traceability in Brazil
June 30, 2025
The National Health Surveillance Agency (ANVISA) is taking important steps towards the modernization of the regulation of medical devices in Brazil, with the implementation of the Unique Medical Device Identification (UDI) and the National UDI System (SIUD). These measures are part of an international movement aimed at improving traceability, patient safety and integration with national and global health databases.
What is UDI?
UDI (Unique Device Identification) is an international standard that allows each medical device to be uniquely identified. This identification is done through a standardized label with codes readable by humans and by automated equipment such as barcode readers.
The aim is to promote the accurate and efficient traceability of these products, from their manufacture to their final use in hospital or ambulatory environments. This allows for a more agile response in cases of recall, inspection and control of adverse events.
What is SIUD?
The SIUD will be the National Unique Identification System for Medical Devices, a database that will concentrate information about the products registered and notified with ANVISA. The proposal is that the UDI data of each device be integrated into this system, which, in turn, will also be able to interact with the National Health Data Network (RNDS).
This level of integration will strengthen health control in Brazil and allow public and private managers to have access to more reliable and standardized information about the devices in use in the country.
What are the deadlines?
The implementation of UDI labeling will be carried out in a staggered manner, according to the medical device risk category, following the logic of higher criticality first:
- Class IV: July 2025
- Class III: to be defined
- Class II: to be defined
- Class I: deadline January 2028
The mandatory transmission of data to the SIUD is linked to the publication of the Normative Instruction that will regulate this procedure. This standard is currently under Public Consultation N° 1313/2025, with publication scheduled for July 2025.
How should companies prepare?
The implementation of UDI and SIUD represents a new regulatory framework for the medical device industry. Manufacturers, importers and distributors must act in advance to comply with the new requirements, avoiding delays or regulatory obstacles.
Among the recommended actions, the following stand out:
- Suitability of labeling and printing systems to meet the UDI standard;
- Organization of databases for future submission to SIUD;
- Training of regulatory teams to deal with technical requirements;
- Updating of internal traceability and inventory control processes.
Licempre can help
With expertise in regulatory affairs and a global presence, Licempre closely monitors the changes promoted by ANVISA and offers full support to companies seeking to adapt to the new standards.
From regulatory interpretation to technical support for UDI implementation, Licempre is ready to help your business evolve safely and in compliance with the requirements of health legislation.
📎 Access public consultation N° 1313/2025:
👉 Click here