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《条例》修订与医疗器械监管法规的完善
引用本文:蒋海洪.《条例》修订与医疗器械监管法规的完善[J].中国医疗器械信息,2011,17(4):44-47.
作者姓名:蒋海洪
作者单位:上海医疗器械高等专科学校,上海,200093
基金项目:上海市选拔优秀青年教师科研专项基金资助项目
摘    要:目前,《条例》正处于紧张的修订当中。文章在总结《条例》以及整个医疗器械监管法规体系所存在问题的基础上,对《条例》修订和医疗器械监管法规的完善作了合理的展望,指出医疗器械监管法规应利用《条例》修订的机会,增强其完整性和科学性。

关 键 词:医疗器械  条例  监管法规  完善

Regulations Revision and Improvement of Supervision Regulations for Medical Devices
JIANG Hai-hong.Regulations Revision and Improvement of Supervision Regulations for Medical Devices[J].China Medical Devices Information,2011,17(4):44-47.
Authors:JIANG Hai-hong
Affiliation:for Medical Devices JIANG Hai-hong Shanghai Medical Instrumentation College(Shanghai 200093)
Abstract:At present,the "regulations" is in among the amendments.The article summarizes some problems which are exist in the "regulations" and the entire legal system of supervision regulations for medical device and forecast reasonably that it should enhance its integrity and scientificalness by using the opportunity to revise "regulations".
Keywords:medical device  regulations  supervision regulations  improvement
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