对欧美国家医疗器械管理模式的探讨与分析

The discussion and analysis about the medical instrument management pattern of European and American countries

通过介绍美国医疗器械监管机构即美国食品药品管理局(FDA)和欧盟在医疗器械领域的三个指令即《有源植入性医疗器械指令》(AIMDD)、《医疗器械指令》(MDD)和体外诊断器械指令(IVDD)具体的监管方法,与中国医疗器械监管体系进行比较和分析,提出一些建议和启示。

We put forward some proposals and the enlightenment through introducing the US medical instrument supervising and managing organization that is American Food Drugs Administrative bureau （FDA） and European Union namely ＂Active Implants Medical instrument dictate＂（AIMDD） in the medical instrument domain three instructions, ＂Medical instrument dictate ＂ （MDD） and in vitro diagnosis instrument dictate （IVDD） concrete supervising and managing method, simultaneously carrying on the comparison and the analysis with the China medical instrument supervising and managing system.