监管科学理念对医疗器械警戒制度建设的启示  

Implications of Regulatory Science for the Construction of Medical Device Vigilance Systems

作　　者：毛振宾 刘树郁 MAO Zhenbin;LIU Shuyu(National Medical Products Administration,NMPA,Beijing 100037,China;Sun YatSen University,SYSU,Guangdong Guangzhou 510275,China)

机构地区：[1]国家药品监督管理局,北京100037 [2]中山大学,广东广州510275

出　　处：《中国药物警戒》2021年第7期601-605,619,共6页Chinese Journal of Pharmacovigilance

摘　　要：通过回顾世界发达国家监管科学的发展历程,结合其对医疗器械警戒体系构建的研究,探讨中国特色医疗器械监管科学和警戒制度的发展思路和方法,提出医疗器械监管科学创新的5个优化战略和建立医疗器械监管科学7个学科,明晰中国特色医疗器械警戒制度建立和创新发展的重点和方向。By reviewing the development of regulatory science in developed countries,and based on the research on the construction of medical device vigilance systems,the evolution and methods of regulatory science and vigilance systems of medical devices in China were explored while five strategies for innovation and optimization and seven disciplines of regulatory science of medical devices were proposed.The priorities for the establishment and innovation of the medical device vigilance system with Chinese characteristics were specified.

关 键 词：监管科学 医疗器械 警戒制度 

分 类 号：R951[医药卫生—药学]