中国创新医疗器械特别审批程序介绍(顾汉卿)-新版特别审批

1、中国创新医疗器械中国创新医疗器械特别审批程序介绍特别审批程序介绍Introduction to Special Approval Procedure on Chinas Innovative Medical Devices中国生物医学工程学会中国生物医学工程学会 顾汉卿顾汉卿Chinese Society of Biomedical Engineering Gu Hanqing 随着科学技术的进步，随着科学技术的进步，医疗器械在临床疾病医疗器械在临床疾病的预防、诊断、治疗的预防、诊断、治疗中的作用越来越显得中的作用越来越显得重要。为了鼓励医疗重要。为了鼓励医疗器械的研究与创新，器械的研究与创新

2、，让更多创新的高科技让更多创新的高科技医疗器械快速受惠于医疗器械快速受惠于普通百姓，中国食品普通百姓，中国食品药品监督管理局颁布药品监督管理局颁布了了创新医疗器械特创新医疗器械特别审批程序（试别审批程序（试行）行）。 With the progress of science and technology, medical devices in the role of clinical disease prevention, diagnosis, and treatment is more and more important. To encourage research and innovat

3、ion in medical devices, so that more innovative high-tech medical devices to rapidly benefit ordinary people, the State Food and Drug Administration (SFDA) issued Special Approval Procedure on Innovative Medical Devices (trial). 一、哪些医疗器一、哪些医疗器械产品属于创新械产品属于创新医疗器械，可以医疗器械，可以申报特别审批。申报特别审批。 I. Which produ

4、cts are innovative medical devices that can declare special approval? 同时符合下列同时符合下列四点的产品属四点的产品属于创新医疗器于创新医疗器械范围。械范围。 The products meeting the following four points are innovative range of medical devices. 1. 1.申请者在中国申请者在中国依法拥有申报产依法拥有申报产品核心技术的发品核心技术的发明专利权，或者明专利权，或者依法通过受让取依法通过受让取得在中国发明专得在中国发明专利权或其使用权；利权

5、或其使用权；或者核心技术发或者核心技术发明专利的申请已明专利的申请已由国务院专利行由国务院专利行政部门公开。政部门公开。 1）The applicant according to the law have the right of invention patent on declaring core technology in China, or according to the law through the transferee obtain the patent right for invention or the right to use in China; or the applic

6、ation of invention patent on core technology has been published by the patent administration department under the State Council. 2. 2.产品主要工产品主要工作原理作原理/ /作用机作用机理为国内首创，理为国内首创，产品性能或者安产品性能或者安全性与同类产品全性与同类产品比较有根本性改比较有根本性改进，技术上处于进，技术上处于国际领先水平。国际领先水平。 2. The main working principle / mechanism of products ar

7、e the first in the country. Product performance or safety compared with similar product has a fundamental improvement, with technically a leading international level. 3. 3.该产品具有该产品具有显著的临床应显著的临床应用价值。用价值。 3. The product has significant value in clinical application. 4. 4.已完成该产已完成该产品的前期研究并品的前期研究并具有基本定型

8、产具有基本定型产品，研究过程真品，研究过程真实和受控，研究实和受控，研究数据完整和可溯数据完整和可溯源。源。 4. Have finished the preliminary research of the product and finalized the designed product. The process of study is real and controlled, with data integrity and traceability. 二、创新医疗二、创新医疗器械特别审批器械特别审批获得通过，有获得通过，有哪些优惠政策哪些优惠政策? ? II. What are the

9、preferential policies for passing the special approval of innovative medical devices? 申请人所在地食申请人所在地食品药品监督管理品药品监督管理部门应当指定专部门应当指定专人，应申请人的人，应申请人的要求及时沟通、要求及时沟通、提供指导。在接提供指导。在接到申请人质量管到申请人质量管理体系检查（考理体系检查（考核）申请后，应核）申请后，应当予以优先办理。当予以优先办理。 The local food and drug supervision and administration authority shall

10、appoint someone, at the request of the applicant, provide guidance for timely communication. Upon receipt of the applicant to check the quality management system (assessment) application, should be given priority. 医疗器械检测机医疗器械检测机构在进行注册检构在进行注册检测时，应当及时测时，应当及时对生产企业提交对生产企业提交的产品标准或技的产品标准或技术要求进行预评术要求进行预评价，

11、对存在问题价，对存在问题的，应当及时向的，应当及时向生产企业提出修生产企业提出修改建议。改建议。 When testing institution for medical devices conducting registration test, should pre-evaluate timely product standards or technical requirements submitted from companies; on the existing problems of the companies, shall be timely proposed amendments.

12、 医疗器械检测机构医疗器械检测机构应当在接受样品后应当在接受样品后优先进行医疗器械优先进行医疗器械注册检测，并出具注册检测，并出具检测报告检测报告。 Testing institution for medical devices shall make a registration test for medical devices in priority after accepting samples , and issue the report. 创新医疗器械的临创新医疗器械的临床试验应当按照医床试验应当按照医疗器械临床试验相疗器械临床试验相关规定的要求进行，关规定的要求进行，食品药品监督管理

13、食品药品监督管理部门应当根据临床部门应当根据临床试验的进程进行监试验的进程进行监督检查。督检查。 Clinical trials of innovative medical devices shall be in accordance with the requirements of related regulations on clinical trials of medical devices. The food and drug supervision and administration department shall make supervision and inspection

14、according to the process of clinical trials. 在产品注册申请受理在产品注册申请受理前以及技术审评过程前以及技术审评过程中，食品药品监管总中，食品药品监管总局医疗器械技术审评局医疗器械技术审评中心应当指定专人，中心应当指定专人，应申请人的要求及时应申请人的要求及时沟通、提供指导，共沟通、提供指导，共同讨论相关技术问题。同讨论相关技术问题。 Before accepting an application for registration of the product and in the process of technical review, Cent

15、er for Medical Device Evaluation of SFDA shall designate someone, at the request of the applicant, provide guidance for timely communication and discuss the related technical problems. 企业可以通过申请与审企业可以通过申请与审评中心指定专人就以下评中心指定专人就以下问题进行沟通交流：问题进行沟通交流： 1. 1. 重大技术问题；重大技术问题； 2. 2. 重大安全性问题；重大安全性问题； 3. 3. 临床试验方案

16、：临床试验方案： 4. 4. 阶段性临床试验结果阶段性临床试验结果 的总结与评价；的总结与评价； 5. 5. 其他需要沟通交流的其他需要沟通交流的 重要问题。重要问题。 Enterprises can apply for communicating with designated person of Evaluation Center on the following issues: 1. Major technical problems; 2. Major safety issues; 3. Clinical trial schemes; 4. Periodic summary and ev

17、aluation of the results of clinical trials; 5. The other important issues that need to communicate. 受理创新医疗器受理创新医疗器械注册申请后，械注册申请后，应当将该注册申应当将该注册申请项目标记为请项目标记为“创新医疗器创新医疗器械械”，并及时进，并及时进行注册申报资料行注册申报资料流转。流转。 After accepting the application for registration of innovative medical devices, the registration item

18、s shall be marked as innovative medical devices, and register to declare information flow in a timely manner. 已受理注册申报已受理注册申报的创新医疗器械，的创新医疗器械，食品药品监管总食品药品监管总局医疗器械技术局医疗器械技术审评中心应当优审评中心应当优先进行技术审评；先进行技术审评；技术审评结束后，技术审评结束后，食品药品监管总食品药品监管总局优先进行行政局优先进行行政审批。审批。 For the innovative medical devices that have been d

19、eclared to accept the registration, Center for Medical Devices Evaluation, SFDA should give priority to the technical review; after the technical evaluation, SFDA is priority to administrative approval. 三、申报创新医三、申报创新医疗器械特别审批疗器械特别审批应准备哪些资料应准备哪些资料? ? III. What information should be ready for declaring

20、 the special approval of innovative medical devices? 1. 1.申请人企申请人企业法人资格证业法人资格证明文件；明文件； 2. 2.产品知识产品知识产权情况及证产权情况及证明文件；明文件； 3. 3.产品研发产品研发过程及结果的过程及结果的综述；综述； 1.Legal person qualification certificates of the applicant; 2.Intellectual property information and supporting documents of products; 3.Summary of

21、product development process and results; 4.4.产品技术文产品技术文 件，至少应当件，至少应当 包括：包括： 产品的预期用产品的预期用 途；途； 产品工作原理产品工作原理/ / 作用机理；作用机理； 4.Technical documents of products should include at least 1) The intended use of products; 2) The working principle and mechanism of products; 产品主要技术指产品主要技术指标及确定依据，主标及确定依据，主要原材料、关

22、键元要原材料、关键元器件的指标要求，器件的指标要求，主要生产工艺过程主要生产工艺过程及流程图，主要技及流程图，主要技术指标的检验方法。术指标的检验方法。 3) The main technical indicators and basis of products, the main raw materials, the index requirements of key components, the main production process and flow chart, and the testing method of main technical indicators. 5. 5

23、.产品创新的证明产品创新的证明性文件，至少应当性文件，至少应当包括：包括： 信息或者专利信息或者专利检索机构出具的检索机构出具的查新报告；查新报告； 核心刊物公开核心刊物公开发表的能够充分发表的能够充分说明产品临床应说明产品临床应用价值的学术论用价值的学术论文、专著及文件文、专著及文件综述；综述； 5. Documented evidence of product innovation include at least 1) The testing report issued by information or patent search agency; 2) Academic papers,

24、 monographs and documents review published in core journals that can fully explain the clinical application value. 国内外已上市国内外已上市同类产品应用情同类产品应用情况的分析及对比况的分析及对比（如有）；（如有）； 产品的创新内产品的创新内容及在临床应用容及在临床应用的显著价值。的显著价值。 3) Analysis and comparison in the application of similar products already listed on the market

25、at home and abroad (if any); 4) The innovation content of products and significant value in clinical application. 6. 6.产品安全风险产品安全风险管理报告。管理报告。 7. 7.产品说明书。产品说明书。 8. 8.其他证明产品其他证明产品符合创新医疗器符合创新医疗器械要求的资料。械要求的资料。 6. A report on safety and risk management of products. 7. Product Manual. 8. Other supporting

26、information that can prove to meet the requirements of innovative medical devices. 9. 9.境外申请人应当委境外申请人应当委托中国境内的企业法托中国境内的企业法人作为代理人或者由人作为代理人或者由其在中国境内的办事其在中国境内的办事机构提出申请，并提机构提出申请，并提交以下文件：交以下文件： 9.An overseas applicant shall entrust a legal person of enterprise in China as an agent or by its offices in Ch

27、ina, apply for and submit the following documents: 境外申请人委境外申请人委托代理人或者其托代理人或者其在中国境内办事在中国境内办事机构办理创新医机构办理创新医疗器械特别审批疗器械特别审批申请的委托书；申请的委托书； 1) Overseas applicants entrust agent or its offices in China to deal with the power of attorney in the applications of special approval for innovative medical devices

28、. 代理人或者申代理人或者申请人在中国境内办请人在中国境内办事机构的承诺书；事机构的承诺书； 代理人营业执代理人营业执照或者申请人在中照或者申请人在中国境内办事机构的国境内办事机构的机构登记证明。机构登记证明。 2) Letter of commitment of agent or applicant from its offices in China; 3) Business license of agent or registration certificate of applicants offices in Chinas.10.10.所提交资料真所提交资料真实性的自我保实性的自我保证声

29、明。证声明。11.11.申报资料应当申报资料应当使用中文。原使用中文。原文为外文的，文为外文的，应当有中文译应当有中文译本。本。 10.Self-declaration by the enterprise to guarantee the truthfulness of the documentation submitted. 11.All documents required to be submitted by an applicant shall be in Chinese; if the original document is in a foreign language, a Chi

30、nese translation shall be provided. 境内申请人应当境内申请人应当向其所在地的省向其所在地的省级食品药品监督级食品药品监督管理部门提出创管理部门提出创新医疗器械特别新医疗器械特别审批申请，当局审批申请，当局于于2020个工作日内个工作日内出具初审意见。出具初审意见。报送国家食品药报送国家食品药品监督管理局。品监督管理局。 A domestic applicant shall apply for special approval of innovative medical devices to the local provincial food and drug

31、 supervision and administration department. And the authorities will issue a preliminary examination opinion within 20 working days, submitting to SFDA. 境外申请人应当境外申请人应当向食品药品监管向食品药品监管总局提出创新医总局提出创新医疗器械特别审查，疗器械特别审查，对符合本程序第对符合本程序第四条规定的形式四条规定的形式要求的予以受理。要求的予以受理。 An overseas applicant shall apply for specia

32、l approval of innovative medical devices to SFDA, which will be accepted in compliance with the provisions of Article IV. 食品药品监管总局食品药品监管总局医疗器械技术审评医疗器械技术审评中心设立创新医疗中心设立创新医疗器械审查办公室，器械审查办公室，授权中国生物医学授权中国生物医学工程学会负责对创工程学会负责对创新医疗器械特别审新医疗器械特别审批申请进行审查，批申请进行审查，并于受理后并于受理后4040个工个工作日内出具审查意作日内出具审查意见。见。 Center for

33、Medical Device Evaluation, SFDA set up review office for innovative medical devices, authorized Chinese Society of Biomedical Engineering is responsible for a review of special approval on innovative medical devices and will issue a preliminary examination opinion within 40 working days. 经创新医疗器械审查办经

34、创新医疗器械审查办公室审查，对拟进行特公室审查，对拟进行特别审批的申请项目，在别审批的申请项目，在食品药品监管总局医疗食品药品监管总局医疗器械技术审评中心网站器械技术审评中心网站将申请人、产品名称予将申请人、产品名称予以公示，公示时间应当以公示，公示时间应当不少于不少于1010个工作日。对个工作日。对于有异议的，应当对相于有异议的，应当对相关意见研究后作出最终关意见研究后作出最终审查决定。审查决定。 Reviewed by the Office for Innovative Medical Devices, for the proposed application on special app

35、roval, announce to the applicant and the product name in the website of Center for Medical Devices Evaluation of SFDA，publicity time shall not be less than 10 working days. For any objection, it shall, after advice to related research, make a decision on the final review. 创新医疗器械审创新医疗器械审查办公室作出审查办公室作出审查决定后，将审查决定后，将审查结果书面通知查结果书面通知申请人，对境内申请人，对境内企业的申请，同企业的申请，同时抄送申请人所时抄送申请人所在地省级食品药在地省级食品药品监督管理部门。品监督管理部门。 After rev