图说中国医疗器械注册申报法规 中英文版

孙  磊PrefaceThe public health and life security are closely associated with the safety and effectiveness of medical devices. Establishing a sound medical device access system, improving premarket control and risk prevention, and strengthening the professional and technical aspects of regulatory policies are important measures to ensure the safety of medical devices.Since the reform and opening-up, thanks to the increasingly improved regulatory systems and advanced regulatory controls for medical devices, the medical device industry has been witnessing a continuous rapid development. Especially from 2018 onwards, a new concept of the full life cycle supervision of medical device has been formed, providing an important technical support to ensure the safety and effectiveness of medical device products and promote the steady development of the medical device industry.In response to the deepening of streamline administration and institute decentralization, combination of the simplification and delegation and optimization of service reformation, this Center organizes to write this book to introduce the relevant regulations and rules on the registration application or filing application of devices and sort out various evaluation and approval procedures of the Center for Medical Device Evaluation (CMDE) to further improve the efficiency and transparency, and implement the reform requirements of the medical device evaluation and approval system.This book introduces the registration and application processes through pictures and texts. This book is easy to read and can be used as a handbook for people from the medical device enterprises, administrative supervision departments,test facilities, advisory bodies and other organizations related to the medical device industry.The medical device industry is a heterogeneous, innovative, and dynamic sector, with never-ending changes and improvements in its concepts,theories,technologies, products and standards. This book has received strong support from the industry during the writing process and would like to thank Zhang Mingdong, Han Lei and Gao Bo for their helpful suggestions on the compilation work. This book may need to be adjusted, added to, deleted from, and so on as time passes. We also welcome the views,comments and suggestions from our readers.Sun Lei

为响应国家深化简政放权、放管结合、优化服务改革，医疗器械技术审评中心组织编写本书，从注册资料方面介绍了器械注册申报或备案申报相关法规、规章，并梳理了审评中心各类审评审批事项，进一步提高工作效率和透明度，贯彻落实医疗器械审评审批制度改革要求。本书通过图文结合的方式对注册申报流程进行了介绍，语言通俗易懂，可作为医疗器械企业科普读物，医疗器械行政监管部门、检测机构、咨询机构工作人员及行业相关人员亦可阅读学习。

第一章绪论1
1. 医疗器械行政许可事项概述1
2. 医疗器械注册和备案概述3
3. 信息查询4
4. 参考资料4
第二章注册流程5
1. 受理前咨询5
2. 分类10
3. 检验16
4. 临床评价24
5. 创新产品审查47
6. 优先审核流程58
7. 备案和注册申报资料准备66
8. 受理70
9. 审评审批76
10. 发补84
11. 发补后咨询91
12. 专家咨询95
13. 发证102
14. 延续105
15. 注册变更109
16. 说明书更改告知116
17. 其他121
第三章注册范本示例137
1. 医疗器械安全有效基本要求清单范本137
2. 综述资料范本144
3. 研究资料范本146
4. 产品技术要求范本149
5. 预评价意见范本151
6. 医疗器械临床试验伦理审查申请与审批表范本152
7. 知情同意书范本154
8. 医疗器械临床试验病例报告表范本156
9. 医疗器械临床试验方案范本159
10. 医疗器械临床试验报告范本164
11. 医疗器械临床试验应当保存的基本文件目录范本167
12. 医疗器械临床试验审批申请受理前沟通交流申请表169
13. 符合性声明范本170
附录 医疗器械制度文件汇总171
医疗器械监督管理条例（国务院令第680号）171
《医疗器械注册管理办法》（国家食品药品监督管理总局令第4号）191
体外诊断试剂注册管理办法（国家食品药品监督管理总局令第5号）206