关键词: font-size:medium, ">医疗器械唯一标识；经营环节；追溯管理； 创新应用

Abstract: Unique device identifier (UDI) is the “ID card” of medical device products and has become the “common language” for the medical devices industry， and is the digital basis of realizing fine management in the whole life cycle of medical devices. The distribution of medical devices is an intermediate link in the whole life cycle of medical devices. Based on relevant laws and regulations on medical device distribution， this study researched the application of UDI in distribution management of medical devices and tried to develop some creative application of UDI in the traceability management of the supply chain of cardiac interventional products. By upgrading and renovating the information-based system， and connecting with the UDI database of National Medical Products Administration， to realize the scanning code management of medical device products that have been assigned UDI code by the manufacturers， and improve the distribution safety of medical device and supply chain efficiency. By self-developed dispatching system， and using UDI as the clue， realized the traceability of end-to-end data and application of inventory management in the supply chain of cardiac interventional products， which can provided reference for distributing enterprises in the whole life circle management and full process traceability of medical devices.

Key words: font-size:medium, ">Unique device identifier； Distribution； Traceability management； Creative application