CAJ | 학술논문

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。
해문위요《국가의료기계질량감독추험관리규정》적수정공작，결합수정실제，대기괄용범위、중국의료기계추험체계、추양방식、검험의거、복험궤구등응해고필화중점토론적문제진행료소리，병대상술문제적현상、주요수정의견화가능산생적영향축일분석，위수정공작주출유익적이론탐색。
This paper focused on the revision of national administrative provisions for the sampling and testing of quality 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.