| 引用本文：汪楠,田玲.部分国家与地区医疗器械监管现状及对我国的启示[J].中国卫生政策研究,2009,2(11):59-62 |
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| 部分国家与地区医疗器械监管现状及对我国的启示 |
| 投稿时间：2009-06-23 修订日期：2009-07-02 PDF全文浏览 HTML全文浏览 |
| 汪楠, 田玲 |
| 中国医学科学院医学信息研究所 |
| 摘要:本文对美国、欧洲、日本等国家与地区以及国际协调组织医疗器械监管工作开展现状进行简要分析，对比我国现阶段医疗器械监管工作中存在的问题，提出我国医疗器械监管工作需重点加强法律法规建设、统一监管标准、建立与完善上市后监管体系、进一步深化对外交流与合作。 |
| 关键词:医疗器械 监管 现状 启示 |
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| Status quo of medical device supervision in some countries and areas and its implication to China |
| WANG Nan, TIAN Ling |
| Institute of Medical Information, Chinese Academy of Medical Sciences |
| Abstract:This article analyzes the status quo of medical device supervision in some countries and areas, such as US, Europe and Japan etc, as well as the work that Global Harmonization Task Force(GHTF) and Asia Harmonization Work Party(AHWP) carry out. According to the problems of medical device supervision in China, it proposes we should improve the laws and regulations, unify the supervision standard, complete the system of supervision on the market and enhance the cooperation home and abroad. |
| Key words:Medical device, Supervision, Status quo, Implication |
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