原国家食品药品监督管理总局(现国家药品监督管理局)充分落实中共中央和国务院有关深化医疗器械审评审批改革,鼓励医疗器械产业创新发展的意见,在具体实践中,扩大免于进行临床试验医疗器械的目录,滚动推进医疗器械注册技术审查指导原则、开展具体产品分类调整工作,从而保证医疗器械审查的科学性。
<<CFDA(CNDA)fully implement the Opinions of the CPC Central Committee and the State Council on Deepening of medical device review and approval reform,encourage the innovation and development of medical device industry,in specific practice,expand catalogue of clinical trial exemption,promote medical device registration technical review guidelines,carry out specific product classification adjustment work,so as to ensure the scientific of the medical device review and approval work.
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