关键词: font-size:medium, ">UDI, 全生命周期；医疗机构；应用分析；展望

Abstract: Unique device identifier (UDI) is the "ID card" of medical device products， which is the “international common language” for medical devices. The implementation of UDI is conducive to the improvement of fine management of the production， distribution and use of medical devices and is the basis for the digital transformation of medical device industry. In 2019，the National Medical Products Administration(NMPA) issued the Rules for the Unique Identification System of Medical Devices， marking the official launch of UDI in China. Since the implementation of UDI in China two years ago， medical device manufacturers， distributors and medical institutions have carried out various applications and explorations based on UDI. This study reviewed the implementation background of UDI in China， the current situation of "three medical linkage" to promote the implementation of UDI system， summarized the application basis of UDI and the application of UDI in the whole life cycle of medical devices， discussed the feasibility of connecting UDI with the classification code of medical insurance medical consumables and the feasibility of its application in drug regulatory departments， and combined with the experience， put forward thinking and suggestions on accelerating the application of UDI， aiming to facilitate the implementation of UDI in China.

Key words: UDI, Full life cycle, Medical institutions, Application analysis, Outlook