我国医疗器械现代化治理体系构建研究  

Research on the Construction of Modern Governance System of Medical Devices in China

作　　者：刘洋[1] 蒋海洪[1] 幸嵘 LIU Yang;JIANG Hai-hong;XING Rong(Shanghai University of Medicine&Health Sciences)

机构地区：[1]上海健康医学院

出　　处：《中国食品药品监管》2024年第9期164-173,共10页China Food & Drug Administration Magazine

基　　金：2023年中国药品监督管理研究会课题(2023-Y-Q-004)。

摘　　要：新质生产力的发展迫切需要构建现代化的治理体系。本文针对我国医疗器械安全治理的关键核心问题,从医疗器械现代化治理的价值目标、治理框架与实现路径等方面,对构建符合我国国情的医疗器械现代化治理体系进行了探索。本文基于国内外治理理论与我国医疗器械行业监管现状,认为应当重新审视安全有效原目标,及时确立可用可及新目标。提出通过营造多元化的社会共治格局、构建跨部门的协同治理机制和推动专业性的监管力量成长等手段重构我国医疗器械的现代化治理体系框架,并从法治化、科学化、数字化、国际化等角度探讨了优化治理体系的实现路径。The development of new productivity urgently calls for the establishment of a modern governance system.Aiming at the core issues of medical device safety governance in China,this paper explores the construction of a modernization governance system for medical devices in line with China's national conditions from the aspects of value goals,governance frameworks,and implementation paths.Based on both domestic and international governance theories and the current regulatory status of China's medical device industry,the paper suggests a reassessment of the original goal of"safety and efficacy",while proposing the timely establishment of new goals of"availability and accessibility".The modernization of China's medical device governance framework should be reconstructed through fostering a diversified social governance model,building cross-departmental collaborative governance mechanisms,and promoting the development of professional regulatory expertise.Besides,the implementation path to optimize the governance system is discussed from the perspectives of legalization,scientization,digitization,and internationalization.

关 键 词：医疗器械 现代化 治理体系 社会共治 

分 类 号：R95[医药卫生—药学]