关键词: font-size:medium, ">医疗器械唯一标识（UDI）；生产企业；合规

Abstract: The regulations related to the unique device identifier (UDI) of medical devices are gradually implemented in the world. As an international common language in the field of medical devices， UDI is the focus of attention from all over the world. The implementation of UDI will help promote the digital transformation of the medical device industry， and play an important role in improving the management efficiency and level of medical device industry and improving the safety level of clinical use of medical devices. National Medical Products Administration (NMPA) of China issued the UDI System Rules in August 2019， and it was officially implemented in October 2019. Chinese medical device manufacturers have implemented the UDI regulation to varying degrees. From the perspective of medical device manufacturers， this paper introduces the experience of manufacturing enterprises in the interpretation of UDI regulations， the establishment of compliance teams， and the implementation in each phases， expounds the global regulation compliance trend of UDI， especially the difficulties and thoughts in the compliance of UDI regulations， so as to analyze and introduce the key points of UDI regulation compliance of manufacturing enterprises from the first perspective， and to provide reference and ideas for all entities and phases in the medical device industry to better promote UDI implementation.

Key words: font-size:medium, ">Unique device identifier (UDI)； Manufacturing enterprises； Regulation compliance