生产企业对于UDI合规的实践与思考

Practice and Reflection of Manufacturing Enterprises on the Compliance of UDI Regulations

医疗器械唯一标识(UDI)相关法规在全球逐步推行,UDI作为医疗器械领域的国际通用语言,是世界各国关注的热点。推行UDI将有利于促进医疗器械产业数字化转型,对于提高行业管理效能和水平、提升医疗器械临床使用安全水平具有十分重要的作用。我国国家药品监督管理局于2019年8月发布并于同年10月正式实施《医疗器械唯一标识系统规则》。我国医疗器械生产企业均已不同程度实施了UDI的合规工作。本研究从医疗器械生产企业视角,介绍了生产企业在对中国UDI法规的解读、合规团队建立、各环节落地实践等方面的经验,并对UDI全球合规趋势,尤其是UDI合规落地执行中的困难与思考进行了阐述,旨在从UDI合规执行第一视角分析介绍生产企业UDI合规落地要点,为医疗器械行业全生命周期内各主体、各环节更好地推进UDI工作提供借鉴和思路。

The regulations related to the unique device identifier(UDI)of medical devices are gradually implemented in the world.As an international common language in the field of medical devices,UDI is the focus of attention from all over the world.The implementation of UDI will help promote the digital transformation of the medical device industry,and play an important role in improving the management efficiency and level of medical device industry and improving the safety level of clinical use of medical devices.National Medical Products Administration(NMPA)of China issued the UDI System Rules in August 2019,and it was officially implemented in October 2019.Chinese medical device manufacturers have implemented the UDI regulation to varying degrees.From the perspective of medical device manufacturers,this paper introduces the experience of manufacturing enterprises in the interpretation of UDI regulations,the establishment of compliance teams,and the implementation in each phases,expounds the global regulation compliance trend of UDI,especially the difficulties and thoughts in the compliance of UDI regulations,so as to analyze and introduce the key points of UDI regulation compliance of manufacturing enterprises from the first perspective,and to provide reference and ideas for all entities and phases in the medical device industry to better promote UDI implementation.