The Unique Device Identification (UDI) System is intended to provide a single, globally harmonized system for identification of medical devices. It is expected to improve patient safety, facilitate and improve the recall process, and create efficiencies within the medical system.
There are currently no global definitions of what constitutes a UDI or UDI System. As a consequence, discrepancies between different national approaches do exist and will most likely increase.
With the acceptance of FDA’s final rule, US has joined the list of countries that have successfully implemented UDI. Throughout the globe, UDI regulations are in the final phase of adoption, and these laws will have strict compliance deadlines.
We at Global Regulatory Partners believe that for Medical Device/IVD companies selling devices in foreign markets, it is essential to get familiar with the regulations pertaining to UDI. We can help you to comply with the new requirements in the most efficient manner possible.
For a complete overview on UDI for medical devices, global implications and future trends, please click here.