二类医疗器械注册申报资料目录

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

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精品文档

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

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精品文档

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

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