关键词: 医疗器械唯一标识（UDI）, 美国食品药品管理局, UDI系统法规体系和组织架构, UDI系统项目推进情况

Abstract: The unique device identifier(UDI) has become the common language for identification of medical device globally. Since September 2013, the US Food and Drug Administration (FDA) issued unique device identification system（UDI system）regulations to establish a UDI system, which not only standardized data formats for healthcare industry and improved the accuracy of collecting clinical data, but also provided experience for UDI''s global harmonization efforts. Combining with the experience from the field study to US FDA about UDI in 2016, this article outlines the regulatory system and organizational structure of UDI system implementation and the promotion of UDI system projects, discusses the specific implementation plan of UDI system in the United States, and analyzes the UDI issuing agency and global UDI database. The UDI system implementation method with United States characteristics provides experience for China to carry out and promote the implementation of UDI system.

Key words: Unique device identifier（UDI）, The US Food and Drug Administration, UDI system regulatory system and organizational structure, UDI system project promotion