摘要
该文围绕《国家医疗器械质量监督抽验管理规定》的修订工作,结合修订实际,对其适用范围、中国医疗器械抽验体系、抽样方式、检验依据、复验机构等应该考虑和重点讨论的问题进行了梳理,并对上述问题的现状、主要修订意见和可能产生的影响逐一分析,为修订工作做出有益的理论探索。
This paper focused on the revision of national administrative provisions for the sampling and testing of quafity supervision on medical devices, according to the practice, it introduced the scope of application, Chinese system of sampling and testing on medical devices, the methods of sampling, inspection standards, re-inspection institutes and the other issues should be taken into consided and discussed. The current situation of these issues, main idea of the revision and influences of the provisions were also analyzed to provide theoretical exploration for the revision.
出处
《中国医疗器械杂志》
CAS
2013年第5期373-375,378,共4页
Chinese Journal of Medical Instrumentation
关键词
医疗器械
抽验
管理规定
修订
medical devices, sampling and testing, administrative provisions, revision
