| 关于与WTO接轨的医疗器械市场准入模式探讨 |
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| 引用本文： | 黄嘉华,钱虹,凌海萍,吴迎娟,汪泽. 关于与WTO接轨的医疗器械市场准入模式探讨[J]. 中国医疗器械杂志, 2003, 27(1): 54-60 |
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| 作者姓名： | 黄嘉华 钱虹 凌海萍 吴迎娟 汪泽 |
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| 作者单位： | 上海市药品和医疗器械审评中心 |
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| 摘 要： | 介绍上海地区贯彻《医疗器械监督管理条例。,医疗器械市场准入的基本情况,引荐国际惯例,探讨与WTO接轨的医疗器械市场准入模式。
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| 关 键 词： | WTO 医疗器械 市场准入模式 |
| 文章编号： | 1671-7104(2003)01-0054-07 |
| 修稿时间： | 2002-09-09 |
A Discussion about Medical Devices' Premarket Submission Modes for Joining the WTO |
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| HUANG Jia-hua,QIAN Hong,LING Hai-ping,WU Ying-juan,WANG Ze Shanghai Drug and Medical Devices Evaluation Center. A Discussion about Medical Devices' Premarket Submission Modes for Joining the WTO[J]. Chinese journal of medical instrumentation, 2003, 27(1): 54-60 |
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| Authors: | HUANG Jia-hua QIAN Hong LING Hai-ping WU Ying-juan WANG Ze Shanghai Drug Medical Devices Evaluation Center |
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| Abstract: | This article introduces international conventions and discusses medical devices' premarket submission modes forjoining the WTO, having made a survey of the situation in carrying out the document "Medical Devices Administration Regulations" and medical devices premarket admissions in Shanghai. |
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| Keywords: | FDA administration premarket admission |
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