中国医疗器械信息
中國醫療器械信息
중국의료기계신식
CHINA MEDICAL DEVICES INFORMATION
2014年
11期
1-4,9
,共5页
医疗器械%监督管理条例%风险管理%差异
醫療器械%鑑督管理條例%風險管理%差異
의료기계%감독관리조례%풍험관리%차이
medical device%supervision and management regulations%risk management%difference
本文主要对新旧医疗器械监督管理条例进行理解分析，在此基础之上着重分析二者在医疗器械的定义、分类、注册管理和质量管理等方面的差异与联系，从而帮助读者进一步理解医疗器械监管工作的趋势和方向。
本文主要對新舊醫療器械鑑督管理條例進行理解分析，在此基礎之上著重分析二者在醫療器械的定義、分類、註冊管理和質量管理等方麵的差異與聯繫，從而幫助讀者進一步理解醫療器械鑑管工作的趨勢和方嚮。
본문주요대신구의료기계감독관리조례진행리해분석，재차기출지상착중분석이자재의료기계적정의、분류、주책관리화질량관리등방면적차이여련계，종이방조독자진일보리해의료기계감관공작적추세화방향。
This paper mainly analyzed and understood the new and old medical equipment supervision and management regulations, on the basis of the above, compared and analyzed the differences and relations on medical device classiifcation, registration management and quality management and so on, in order to help the readers further understand the trend and direction of the supervision of medical devices, And talked about some of the understanding of the new regulations, only to supply reference.
