| 无需前置许可便能经营的第二类医疗器械监管工作亟待加强 |
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| 引用本文： | 杨祚培. 无需前置许可便能经营的第二类医疗器械监管工作亟待加强[J]. 中国药事, 2011, 25(6): 531-534,540 |
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| 作者姓名： | 杨祚培 |
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| 作者单位： | 湖北省罗田县食品药品监督管理局,罗田,438600 |
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| 摘 要： | 目的探讨对无需前置许可便能经营的第二类医疗器械的有效监管措施。方法对二类器械经营现状、存在的问题、主要原因、监管难点等进行系统分析。结果目前二类器械市场比较混乱,基本上处于失控状态。结论应采取备案经营管理制度、建立索证索票查验制度、加强从业人员培训、加大舆论宣传工作力度、开展源头打假等措施,切实加强对二类器械的监管,以维护医疗器械市场的正常秩序,保证公众使用二类器械安全有效。
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| 关 键 词： | 二类医疗器械 经营使用行为 规范 |
Reinforament on the Supervision and Management of Marketing the Second Category of Medical Apparatus and Instruments withont Pre-Licensing |
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| Yang Zuopei. Reinforament on the Supervision and Management of Marketing the Second Category of Medical Apparatus and Instruments withont Pre-Licensing[J]. Chinese Pharmaceutical Affairs, 2011, 25(6): 531-534,540 |
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| Authors: | Yang Zuopei |
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| Affiliation: | Yang Zuopei(Food and Drug Administration Bureau in Luotian,Hubei Province,Luotian 438600) |
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| Abstract: | Objective To find measures of supervision and management of marketing the second category of medical apparatus and instruments without pre-licensing.Methods To make a systematic analysis of the present situation,the problems,the main causes and the supervising difficulties of the second category of medical apparatus and instruments.Results At present the market of the second category of medical apparatus and instruments was in a state of chaos,basically it is almost out of control.Conclusion Such measures m... |
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| Keywords: | the second category of medical apparatus instruments management and using behaviour standard |
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