医疗器械监管科学与循证科学

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英文篇名：Regulatory science for medical devices and evidence-based science 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 英文作者：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;Engineering Research Center in Biomaterial, Sichuan University;China Evidence-based Medicine Center, West China Hospital, Sichuan University;Life College of Northwest Polytechnic University;Sichuan Food and Drug Inspection and Testing Institute;Sichuan Medical Device Biomaterials and Products Inspection Center; 关键词：监管科学 ; 医疗器械 ; 循证科学 ; 循证医学 ; 安全 ; 有效 英文关键词：Regulatory science;;Medical device;;Evidence-based science;;Evidence-based medicine;;Safety;;Effectiveness 中文刊名：ZZXZ 英文刊名：Chinese Journal of Evidence-Based Medicine 机构：国家药品监督管理局医疗器械监管科学研究基地四川大学医疗器械监管科学研究院;四川大学生物材料工程研究中心;四川大学华西医院中国循证医学中心;西北工业大学生命学院;四川省食品药品检验检测院;四川医疗器械生物材料和制品检验中心; 出版日期：2019-05-25 出版单位：中国循证医学杂志 年：2019 期：v.19 语种：中文; 页：ZZXZ201905006 页数：5 CN：05 ISSN：51-1656/R 分类号：29-33

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.

引文

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    2国家药品监督管理局(2018年第83号公告).关于发布创新医疗器械特别审查程序的公告. Available at:http://www.nmpa.gov.cn/WS04/CL2093/331560.html.
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