Unique Device Identifier (UDI) system is built to keep track of each medical device from production to end user. UDI plays an important role in analyzing adverse event data and providing reliable and consistent identification of medical devices that secures the quality of product surveillance. Through establishing UDI, both TFDA and manufacturers may better identify potential problems or device defects, leading to the improvement of patient welfare.
TFDA has announced a draft schedule of the implementation of UDI system (Figure 1). Starting from June 1st, 2021, class 3 implantable medical devices are the first round of products that are required to comply with this regulation; followed by class 3 non-implantable medical devices starting from June 1st, 2022, and finally, class 2 medical devices starting from June 1st, 2023. Medical device certificate representatives should upload their Device Identifier (DI) and other related information to the UDID platform before distributing medical devices.
Figure 1. Draft Schedule of UDI System Implementation, Announced by TFDA.
TFDA Notice: Drafting of “Requirements for Indicating the Unique Device Identifier on Medical Device Labels”