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