中国医疗器械信息
中國醫療器械信息
중국의료기계신식
CHINA MEDICAL DEVICES INFORMATION
2012年
12期
40-43
,共4页
医疗器械%管理
醫療器械%管理
의료기계%관리
medical devices%regulation
本文主要介绍欧盟医疗器械管理法规的主要内容,重点对欧盟医疗器械三个指令、上市前管理、上市后监督等进行了介绍,提出相应借鉴和启示.
本文主要介紹歐盟醫療器械管理法規的主要內容,重點對歐盟醫療器械三箇指令、上市前管理、上市後鑑督等進行瞭介紹,提齣相應藉鑒和啟示.
본문주요개소구맹의료기계관리법규적주요내용,중점대구맹의료기계삼개지령、상시전관리、상시후감독등진행료개소,제출상응차감화계시.
This article mainly discuss the main contents of laws and regulations of the European Union medical devices managing organization. Introducing with an emphasis on the medical devices domain three instructions of European Union, managment before enter the market and supervision after enter the market etc. we put forward some experiences and enlightenment.
