上海:发布第二类医疗器械优先审批程序 提升审批效率

金融界
Jul 28
剧上海市人民政府网,上海市药品监督管理局发布《第二类医疗器械优先审批程序》,旨在优化医疗器械审评审批流程,保障临床使用需求。该程序针对列入国家或市科技重大项目的器械,以及诊治罕见病、老年病和儿童病的器械,提供优先审批通道。符合条件的申请需提交相关证明材料,经审核后可进入优先审批程序。新规自2025年9月1日起实施,有效期至2030年8月31日,旨在加快优质医疗器械的上市速度。

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