Realization of the Full-process Traceability Management of
Medical Device Supply Chain Based on UDI
LI Yang1，LIU Yazhi1，ZHAO Yu1，ZHANG Feng1，ZHOU Weiping2，ZHOU Qiang3，LIU Guo1，ZHOU Lei1，WANG Xiaorui1
1. China National Medical Device Co., Ltd., Beijing 100028, China| 2. Department of Medical Equipment, Jinshan Hospital of
Fudan University, Shanghai 200540, China| 3. Medical Technology Academy of Sinopharm Group Co., Ltd., Beijing 100028, China
Abstract：Objective To identify the whole chain data of supply chain of medical devices based on unique device identification (UDI)
and information technology, strengthen life cycle management of medical devices, realize full process traceability of medical device
supply chain and ensure the safety of medical devices. Methods The product lines covering high-value consumables, low-value
consumables, in vitro diagnostic reagents and orthopedic consumables were selected in the pilot project. The full process traceability
information system of medical devices was applied to give full advantages of intermediate links in the supply chain of medical
devices and promote the completion of UDI-based information identification and recording from three segments: production,
distribution and application respectively. Results The full process traceability management of high-value consumables, low-value
consumables, in vitro diagnostic reagents and orthopedic consumables was realized. Conclusion The realization of UDI-based full
process traceability management of medical devices in various pilot products provides a demonstration and reference for the main
body of each segment in the medical device supply chain in China to realize product traceability.
李杨1，刘亚芝1，赵宇1，张锋1，周卫萍2，周强3，刘郭欢1，周蕾1，王小蕊1. 基于UDI实现医疗器械供应链全程追溯管理[J]. 中国医疗设备, 2021, 36(2): 8-12.
LI Yang1，LIU Yazhi1，ZHAO Yu1，ZHANG Feng1，ZHOU Weiping2，ZHOU Qiang3，LIU Guo1，ZHOU Lei1，WANG Xiaorui1. Realization of the Full-process Traceability Management of
Medical Device Supply Chain Based on UDI. China Medical Devices, 2021, 36(2): 8-12.
