The new Circular issued by ANVISA, aims to inform the regulated sector of the guidelines and mandatory implementation schedule for the Unique Medical Device Identification (UDI) system.

This system seeks to guarantee the unambiguous identification of medical devices during their distribution and use, thus raising patient safety standards in Brazil, in line with the international standards of the IMDRF (International Medical Device Regulators Forum).

Starting July 10, 2025, the UDI will become mandatory for Class IV medical devices manufactured from that date. For other risk classes (III, II, and I), the obligations will be scaled annually until January 2028. In the case of reusable devices, an additional two-year period is granted for permanent marking on the device body. However, since 2020, the inclusion of UDIs has been mandatory for certain specific products, such as coronary stents and implants for hip and knee replacements.

WHOM DOES IT IMPACT?

The direct impact is on medical device manufacturers, importers and distributors, regulatory compliance, logistics, and technology departments, healthcare facilities, and patients.

CONCLUSION:

This is a highly significant regulatory transformation, comparable to other international regulatory frameworks, which will entail significant changes throughout the entire supply chain of the medical device sector in Brazil.