Brazil's ANVISA Public Consultation: Transforming Medical Device Identification

The National Health Surveillance Agency ANVISA has launched a public consultation to receive contributions on the requirements for the transmission and management of the Brazilian Unique Medical Device Identification (UDI) database.

The UDI is an international identification standard that facilitates the identification of medical devices on the market, with the primary objective of increasing patient safety. This standard was established by the Collegiate Directive Resolution (RDC) No. 591/2021.

The public consultation focuses on the proposal for a regulatory instruction that establishes the basic conditions for submitting UDI data to ANVISA. The database, called the Unique Device Identification System (SIUD), is now ready to receive data from companies.

**WHY? **

The public consultation on the Unique Medical Device Identification (UDI) database has a high impact as it is designed to improve patient safety by facilitating the accurate identification of medical devices. This can reduce medical errors and improve device traceability in the event of problems or recalls.

The regulation establishes a clear framework for the transmission and management of UDI data, which can increase transparency and compliance with health regulations. This is crucial for maintaining high standards in the medical device industry.

Adopting international standards such as the UDI can boost innovation and competitiveness in the Brazilian medical device market, aligning it with global best practices.

Implementing the UDI can have significant economic implications for companies that manufacture and distribute medical devices, as they will need to adapt their systems and processes to comply with the new requirements.

**WHO? **

Therefore, the direct impact is on medical device manufacturers, distributors and suppliers, healthcare professionals, and patients.

**CONCLUSION: **

Public consultation and implementation of the UDI have a significant impact at multiple levels, from the medical device industry to healthcare professionals and patients.