In June 2022,Beijing Municipal Medical Products Administration,in collaboration with Beijing Municipal Health Commission and Beijing Municipal Medical Insurance Bureau,issued the Quality Improvement Plan for Unique Device Identifier in Beijing.The plan aims to improve the implementation quality of unique device identifier(UDI)through problem identification,training and communication,research and development for long-term mechanisms,and promotion and application.By fully leveraging the leading role of demonstration units,the initiative aims to support better implementation of the UDI system by medical device manufacturers,distributers,and healthcare institutions.In 2022,the Beijing Municipal Medical Products Administration conducted a survey using questionnaires to assess the implementation of UDI for second and third-class medical devices in Beijing.The analysis covered aspects such as medical device registrants,operational enterprises,user units,and the current status of UDI identification label quality.The paper proposes measures to enhance the implementation of UDI by medical device enterprises,intending to serve as a reference and guidance for the implementation and continuous improvement of UDI policies in other regions.
关键词
北京市/医疗器械唯一标识/质量提升/三医联动/示范引领
Key words
Beijing/unique device identifier/quality improvement/tripartite system/demonstration and guidance
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