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. Espely 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。

目录章  绪论11. 医疗器械行政许可事项概述12. 医疗器械注册和备案概述33. 信息查询44. 参考资料4第二章  注册流程51. 受理前咨询52. 分类103. 检验164. 临床评价245. 创新产品审查476. 优先审核流程587. 备案和注册申报资料准备668. 受理709. 审评审批7610. 发补8411. 发补后咨询9112. 专家咨询9513. 发证10214. 延续10515. 注册变更10916. 说明书更改告知11617. 其他121第三章  注册范本示例1371. 医疗器械安全有效基本要求清单范本1372. 综述资料范本1443. 研究资料范本1464. 产品技术要求范本1495. 预评价意见范本1516. 医疗器械临床试验伦理审查申请与审批表范本1527. 知情同意书范本1548. 医疗器械临床试验病例报告表范本1569. 医疗器械临床试验方案范本15910. 医疗器械临床试验报告范本16411. 医疗器械临床试验应当保存的基本文件目录范本16712. 医疗器械临床试验审批申请受理前沟通交流申请表16913. 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）206Chapter Ⅰ Introduction2291. Overview of Administrative Licensing of Medical Devices2292. Overview of Medical Device Filing and Registration2323. Information Inquiry2334. References234Chapter Ⅱ Registration Processes2351. Pre-acceptance Consultation2352. Classification2413. Test2494. Clinical Evaluation2595. Innovative Product Review2876. Priority Review and Approval Processes3007. Preparation of Recordation and Registration Materials3098. Acceptance3159. Review and approval32110. Deficiency Letter33011. Consultation33812. Expert Consultation34413. Issuing of Certificates35214. Renewal35515. Changes to Registration36116. Notification on IFU Changes 36917. Other matters377Chapter Ⅲ Registration Templates3971. Template for the Essential Requirements Checklist for Safety and Effectiveness of Medical Devices (for reference only)3972. Template for Summary Data4113. Template for Study Data4134. Template for Product Technical Requirements4175. Template for Pre-evaluation Opinion4196. Templates of Ethical Review Application and Approval of Clinical Trials of Medical Devices4207. Template for Informed Consent Form4228. Template for Case Report Form of Medical Device Clinical Trials4259. Template for Clinical Trial Protocol of Medical Devices42810. Template for Clinical Trial Report of Medical Devices43311. List of Basic Documents Recorded during Clinical Trial of Medical Devices43612. Communication Application Form before the Acceptance of Review Application of Medical Device Clinical Trial43913. Template for Statement of Conformity440Attachment Summary of Medical Device System Documents441Regulations on the Supervision and Administration of Medical Devices (Decree No. 680 of the State Council of the People’s Republic of China)441Measures for the Administration of Registration of Medical Devices (Decree No. 4 of China Food and Drug Administration)479Measures for the Administration of Registration of In-Vitro Diagnostic Reagents (Decree No. 5 of China Food and Drug Administration)503