二类医疗器械注册申报资料目录_二类医疗器械注册资料

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目录

1.申请表.............................................................1-4 2.证明性文件.........................................................1-2 3.医疗器械安全有效基本要求清单.......................................1-6 4.综述资料

4.1概述...........................................................1 4.2产品描述.......................................................1 4.3型号规格.....................................................1-2 4.4包装说明.......................................................2 4.5适用范围和禁忌症.............................................2-3 4.6参考的同类产品或前代产品的情况（如有）.........................3 4.7其他需说明的内容...............................................4 5.研究资料

5.1产品性能研究.................................................1-3 5.2生物相容性评价研究...........................................3-4 5.3生物安全性研究.................................................4 5.4灭菌和消毒工艺研究.............................................4 5.5有效期和包装研究...............................................4 5.6动物研究.......................................................5 5.7软件研究.......................................................5 5.8其他...........................................................5 6.生产制造信息

6.1 无源产品/有源产品生产过程信息描述..............................1 6.2生产场地.......................................................2 7.临床评价资料......................................................1-21 8.产品风险分析资料..................................................1-17 9.产品技术要求.......................................................1-5 10.产品注册检验报告...............................................附件1 10.1注册检验报告................................................1-4 10.2预评价意见....................................................5 10.3委托检验报告..............................................附件2 11.说明书和标签样稿

11.1说明书........................................................1 11.2最小销售单元的标签样稿........................................2 12.符合性声明........................................................1-3 13.授权委托书..........................................................1