摘要
医疗器械监管科学是服务于医疗器械监管的科学研究和活动。循证科学所提倡的"科学和透明原则,开展证据为本"的原则也适用于医疗器械监管科学的相关活动,即采用循证科学的工具和方法,通过证据证明产品全生命周期、使用人群、范围的安全有效和质效与成本-效果。循证科学为医疗器械监管科学提供全新的方法和工具,也为制定科学监管决策提供新依据。
Regulatory science of medical devices serves the scientific research and regulatory activities for supervision of medical devices. Principles of science and transparency and conduction of evidence-based study, which is advocated in Evidence-based science(EBS), also apply to regulatory science of medical devices, including using evidencebased scientific tools and methods to demonstrate the safety and effectiveness, as well as quality, efficacy and costeffectiveness of total life cycle of medical products, target customers, and scope. EBS provides both new methods and tools for regulatory science for medical devices, and provides a new basis for further scientific regulatory decisions.
作者
张凯
孙鑫
喻佳洁
唐中岚
付增祥
胥彬
朱向东
梁洁
李幼平
张兴栋
ZHANG Kai;SUN Xin;YU Jiajie;TANG Zhonglan;FU Zengxiang;XU Bin;ZHU Xiangdong;LIANG Jie;LI Youping;ZHANG Xingdong(Research Base of Regulatory Science for Medical Device,National Medical Products Administration,Institute of Regulatory Science for Medical Device,Sichuan University,Chengdu,610064,P.R.China;Engineering Research Center in Biomaterial,Sichuan University,Chengdu,610064,P.R.China;China Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu,610041,P.R.China;Life College of Northwest Polytechnic University,Xi'an,710072,P.R.China;Sichuan Food and Drug Inspection and Testing Institute,Chengdu,611731,P.R.China;Sichuan Medical Device Biomaterials and Products Inspection Center,Chengdu,610064,P.R.China)
出处
《中国循证医学杂志》
CSCD
北大核心
2019年第5期527-531,共5页
Chinese Journal of Evidence-based Medicine
关键词
监管科学
医疗器械
循证科学
循证医学
安全
有效
Regulatory science
Medical device
Evidence-based science
Evidence-based medicine
Safety
Effectiveness
