健康发展与政策研究2025，Vol.28Issue(5)：579-585,7.DOI:10.12458/HDPR.202409043
2017-2024年上海市医疗器械审评审批的实践与革新对策
Practical experience and reform strategies for medical device evaluation and approval in Shanghai from 2017 to 2024
摘要
Abstract
Objective To review and summarize the evolution of medical device evalution and approval practices in Shanghai in recent years,and to offer recommendations for the reform of medical device regulatory system.Methods Data were collected from the annual reports(2017-2024)of the Shanghai Municipal Medical Products Administration,the Shanghai Municipal Bureau of Statistics,and the Shanghai Medical Device and Cosmetics Evaluation and Verification Center.Core indicators,such as review timelines,registration of clinical trial institutions,number of first-time registrations,registrations of innovative medical device,and industrial output value were selected for analysis using both qualitative and quantitative methods.Results The average review time of Class II medical devices in Shanghai was shortened from 300 calendar days in 2017 to 99 calendar days in 2024.The number of first-time registrations of Class II and Class III medical devices increased from 211 and 273 in 2017 to 429 and 286 in 2024,respectively.By the end of 2024,Shanghai had registered 57 innovative medical devices,accounting for 18.1%of the national total(N=315).In 2023,the total output value of Shanghai's medical device industry reached 49.06 billion yuan,with new product sales in the medical equipment manufacturing sector amounting to 17.89 billion yuan,and exports totaling 2.79 billion yuan.Conclusions Although the efficiency of medical device evaluation in Shanghai has significantly improved,the growth in registration number has slowed;the number of marketing approvals has declined;and the industry remains relatively small with insufficient innovation.It is recommended to focus on strategic emerging industries,and promoting policy coordination within the medical device industry in the Yangtze River Delta,and support interdisciplinary collaboration to enhance the commercialization capacity of new products.关键词
医疗器械/审评审批制度/上海市/注册人制度Key words
medical device/evaluation and approval system/Shanghai/marketing authorization holder system分类
药学引用本文复制引用
刘洋,蒋海洪..2017-2024年上海市医疗器械审评审批的实践与革新对策[J].健康发展与政策研究,2025,28(5):579-585,7.基金项目
中国药品监督管理研究会项目(2023-Y-Q-004),上海市教育科学研究一般项目(C24142) （2023-Y-Q-004）
