为促进国内医疗器械产业的创新发展,原国家食品药品监督管理总局在2014年颁布了《创新医疗器械特别审批程序(试行)》,按照早期介入、专人负责、科学审批的原则,在标准不降低、程序不减少的前提下,对创新医疗器械优先审批项目在技术审评过程中予以优先办理。本报告通过对2014~2018年创新医疗器械审批申请及批准注册产品数据进行汇总,采用多维度分析的方式,呈现出国内创新医疗器械发展现状,为相关行业分析提供借鉴参考。
<<In order to promote innovation anddevelopment of domestic medical device industry,the State Food and Drug Administration released the Special Approval ProceduresforInnovative Medical Devices in 2014,according to whichthe innovative medical device will be eligible for priority evaluation and approval procedures by following the principles of early intervention,dedicated persons in chargeand scientific examination and approval,without lowering the standards and reducing the procedures. The authorcollected data about applications of innovative medical devices and approval for product registration between 2014 and 2018. Through multi-dimension analysis,the authordescribed developments in China’s innovative medical devices,giving some insights into industry analysis.
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