《医疗器械技术审评流程》.pdf

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1、医疗器械技术审评流程医疗器械技术审评流程.............................................................................................................1注册主流程.................................................................................................................................1注册申报资料准备.............

2、........................................................................................................21注册申报资料依据.................................................................................................................22注册申报相关要求.................................................

3、................................................................22.1申请表.........................................................................................................................22.2证明性文件.....................................................................................

4、............................22.3医疗器械安全有效基本要求清单.............................................................................22.4综述资料.....................................................................................................................22.5研究资料..............................

5、.......................................................................................22.6生产制造信息.............................................................................................................22.7临床评价资料......................................................................

6、.......................................32.8产品风险分析资料.....................................................................................................32.9产品技术要求.............................................................................................................32.10产品注册检验报告..

7、.................................................................................................32.11产品说明书和最小销售单元的标签样稿...............................................................32.12符合性声明............................................................................................