摘要
Abstract
Since the 14th Five-Year Plan period,China's medical device standard administration has entered a stage of high-quality development.The number of medical device standards has continued to grow,standards in innovative fields have achieved breakthroughs,and participation in international standardization has significantly increased.This paper systematically reviews the latest progress in medical device standard administration from the perspectives of improving regulatory frameworks,optimizing organizational structures,enhancing standard systems,and promoting internationalization level.Considering the new trends in regulation and industrial development,this paper deeply analyzes the emerging characteristics and trends of medical device standard administration,namely the shift from technology following to standard leading,from scale expansion to efficiency improvement,and from decentralized management to systematic administration.On this basis,systematic recommendations are proposed for continuously advancing the high-quality development of medical device standard administration,aiming to provide policy guidance for improving China's medical device standard administration capacity and international competitiveness,and for empowering medical device regulation and industrial innovation.关键词
医疗器械/标准管理/高质量发展/国际对比/现状/展望Key words
medical device/standard administration/high-quality development/international comparison/current status/prospects分类
医药卫生
