关键词: 医疗器械唯一标识（UDI）, 深圳市医疗器械唯一标识（UDI）追溯平台, 三医联动, 全生命周期监管, 数据对接

Abstract:

The promotion and application of unique device identifier （UDI） is being carried out in stages and steps throughout the nation since 2019.Shenzhen has strictly implemented relevant work in accordance with national and provincial/municipal policies， and carried on the fruitful exploration in UDI policy， standard， technology and application.It has built a medical device traceability system through comprehensive efforts in standard-setting， industry promotion， enterprise training， and platform application.The promotion and implementation of UDI has achieved substantial results. It has established a model of “one platform as the foundation， two areas to make efforts， three-department collaboration and four-standard guarantee”. On 14th October 2021， the Shenzhen UDI tracing platform was officially launched which was built for technical support to implement UDI work. The platform collects the information of production， circulation and clinical use of medical devices and uses UDI as the main key. Currently， the platform has collected information of over 80 000 products （UDI-DIs） from more than 400 manufacturers in Shenzhen， more than 1 000 000 pieces of clinical use information from 30 top Shenzhen grade A tertiary hospitals. The tracing platform for UDI in Shenzhen has been built into an actual means to promote UDI work. Currently， the implementation scope of UDI is being expanded in an orderly manner， medical institutions are being added to pilot projects， and data docking methods are being enriched. This study summarizes the challenges encountered in the implementation of UDI and the strategies and methods for addressing them， reviews the achievements of UDI promotion in Shenzhen， and aims to take advantage of the promotion of UDI work as an opportunity to form a replicable experience summary for promoting the application of the " Joint Reformation for Public Health Services，Medical Insurance，and Medical Production-Circulation" and creating a demonstration effect， in order to contribute to the realization of precise traceability of medical devices throughout their life cycle and the high-quality development of Shenzhen's medical device industry.

Key words:  Unique device identifier （UDI）； Tracing platform for UDI in Shenzhen； Joint reformation for public health services,  medical insurance,  and medical production-circulation； Whole life cycle supervision； Data docking