确保医疗器械的有效性和安全性:监管方法的跨国比较。

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2014-01-01
Daniel B Kramer, Yongtian T Tan, Chiaki Sato, Aron S Kesselheim
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引用次数: 0

摘要

监管机构在权衡新型医疗器械的市场批准时,必须仔细平衡其益处和潜在危害。我们对美国、欧盟、日本和中国的设备监管方法进行了法律和政策审查,重点是上市后监管。这些市场具有广泛的特点,如严重依赖被动不良事件收集,反映在对更主动和动态机制(如唯一设备标识)的日益增长的热情。更直接的是,美国和欧盟系统可能会受益于对选定器械的定期、强制性和相应的重新检查,就像日本和中国所做的那样,以加强对患者的上市后保护并促进公共卫生。
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Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation.

Regulatory bodies weighing market approval for novel medical devices must balance the benefits and potential hazards carefully. We performed a legal and policy review of appraoches in the US, EU, Japan, and China to device regulation with a focus on postmarket surveillance. These markets share broad features such as a heavy reliance on passive adverse event collection, reflected by growing enthusiasm for more active and dynamic mechanisms such as unique device identification. More immediately, US and EU systems might benefit from scheduled, compulsory, and consequential re-examination of select devices, as is done in Japan and China, in order to strengthen post-market protection of patients and bolster public health.

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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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