| 体外诊断试剂的监督管理研究 |
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| 引用本文： | 汪泽,钱虹,徐凤玲,黄嘉华,顾维康. 体外诊断试剂的监督管理研究[J]. 中国医疗器械杂志, 2005, 29(2): 124-130 |
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| 作者姓名： | 汪泽 钱虹 徐凤玲 黄嘉华 顾维康 |
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| 作者单位： | 上海市药品和医疗器械审评中心,上海,200052 |
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| 摘 要： | 通过对美国与我国体外诊断试剂的定义、分类、准入模式及其它管理特点的比对介绍,结合我国体外诊断试剂的生产及管理现状的分析,指出要进一步完善我国体外诊断试剂的监督管理,需要使监督管理方式与体外诊断试剂的自身特点保持内在的一致.
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| 关 键 词： | 体外诊断试剂 医疗器械 监督管理 |
| 文章编号： | 1671-7104(2005)02-0124-07 |
| 修稿时间： | 2004-04-27 |
Studies on Administration of In -Vitro Diagnostic Reagents |
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| WANG Ze,QIAN Hong,XU Feng-ling,HUANG Jia-hua,GU Wei-kang. Studies on Administration of In -Vitro Diagnostic Reagents[J]. Chinese journal of medical instrumentation, 2005, 29(2): 124-130 |
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| Authors: | WANG Ze QIAN Hong XU Feng-ling HUANG Jia-hua GU Wei-kang |
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| Affiliation: | Shanghai Municipal Drug and Medical Device Evaluation Center. |
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| Abstract: | This article introduces the definition, classification, premarket admission and other administering specialities about In-Vitro Diagnostic Reagents in the U.S.A. and China. And by analyzing manufacture and administration of In-Vitro Diagnostic Reagents in our country, It is pointed out that a suitable administering model in accordance with the characteristics of In-Vitro Diagnostic Reagents should be adopted to perfect the administration. |
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| Keywords: | FDA |
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