医疗器械唯一标识追溯管理的探索与思考

Explore and Reflection of Unique Device Identifier(UDI)in the Traceability Management

医疗器械唯一标识(unique device identifier,UDI)是医疗器械产品的“身份证”,是医疗器械管理重要基础性工作之一。《医疗器械监督管理条例》明确将UDI制度纳入到国家医疗器械监管法治体系。2019年7月起,国家药品监督管理局启动UDI系统试点工作。天津成为首批试点省份并承担UDI法规研究组牵头职责。为更好地推进UDI系统试点工作,探索研究UDI追溯对医疗器械监管的重要意义,天津市药品监督管理局以三医联动模式开展全域推广,运用信息化手段搭建系统实现追溯串联,并在监管中不断拓展应用,探索了UDI全面实施的可行性。本研究结合天津市在UDI管理中的探索与实践,解读UDI追溯管理的难点与痛点,并结合实践就UDI准确性、全域推广和全链条追溯等方面总结经验与启示。

Unique device identifier(UDI)is the“ID card”of medical device products,which is one of the imortant basic works in medical device management.The revised Regulations on the Supervision and Administration of Medical Devices clearly incorporate the UDI regulation into the national medical device regulatory legal system.From July 2019,the National Medical Products Administration(NMPA)started the pilot work of the unique device identification system(UDI system).Tianjin became one of the first pilot provinces and took on the leading role of the UDI regulatory research group.In order to promote the pilot work of the UDI system and explore the important significance of UDI traceability in medical device administration.Tianjin Medical Products Administration promote the whole region UDI application based on"three medical linkage",use information technology to build a system for traceability that links different stages,which is increasingly applied in regulatory contexts,and explored the feasibility of the full implementation of UDI.This study combineed the exploration and practice of Tianjin UDI management,interpreted the difficulties and pain points of UDI traceability man⁃agement,and put forward the experience and enlightenment of UDI accuracy,comprehensive promotion and full-chain traceability from the practical exprience.