摘要
本文简单介绍了中国医疗器械质量管理体系规范、欧盟医疗器械指令、ISO13485标准和美国FDA对厂房设施和环境的要求,并进行了简单的比较,目的是为医疗器械制造商在理解相关法规时,提供借鉴。
In this paper, it simply introduce requirement for facility and environment separate in China medical device Quality System Regulation, Europe medical device Directive, ISO13485 standard and FDA medical device Quality system regulation. The comparison is made to help medical device industry understand the regulation requirement.
出处
《中国医疗器械信息》
2012年第9期4-7,66,共5页
China Medical Device Information
关键词
厂房设施
环境
医疗器械质量体系
facility, environment, medical device quality system
