Requirement for facility and environment of FDA, regulation of China medical device Quality System, Europe medical device Directive and ISO13485 standard are introduced. The comparison is made to help domestic medical device industry understand the regulation requirement.%介绍了中国医疗器械质量体系规范、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,为我国医疗器械制造商在理解相关法规时提供借鉴.
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