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1、中国创新医疗器械 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 顾汉卿 Chinese Society of Biomedical Engineering Gu Hanqing,随着科学技术的进步，医疗器械在临床疾病的预防、诊断、治疗中的作用越来越显得重要。为了鼓励医疗器械的研究与创新，让更多创新的高科技医疗器械快速受惠于普通百姓，中国食品药品监督管理局颁布了创新医疗器械特别审批程序（试行）。,With the progress of sci
2、ence and technology, medical devices in the role of clinical disease prevention, diagnosis, and treatment is more and more important. To encourage research and innovation in medical devices, so that more innovative high-tech medical devices to rapidly benefit ordinary people, the State Food and Drug
3、 Administration (SFDA) issued Special Approval Procedure on Innovative Medical Devices (trial).,一、哪些医疗器械产品属于创新医疗器械，可以申报特别审批。,I. Which products are innovative medical devices that can declare special approval?,同时符合下列四点的产品属于创新医疗器械范围。,The products meeting the following four points are innovative range
4、of medical devices.,1.申请者在中国依法拥有申报产品核心技术的发明专利权，或者依法通过受让取得在中国发明专利权或其使用权；或者核心技术发明专利的申请已由国务院专利行政部门公开。,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 th
5、e right to use in China; or the application of invention patent on core technology has been published by the patent administration department under the State Council.,2.产品主要工作原理/作用机理为国内首创，产品性能或者安全性与同类产品比较有根本性改进，技术上处于国际领先水平。,2. The main working principle / mechanism of products are the first in the c
6、ountry. Product performance or safety compared with similar product has a fundamental improvement, with technically a leading international level.,3.该产品具有显著的临床应用价值。,3. The product has significant value in clinical application.,4.已完成该产品的前期研究并具有基本定型产品，研究过程真实和受控，研究数据完整和可溯源。,4. Have finished the prelimi
7、nary research of the product and finalized the designed product. The process of study is real and controlled, with data integrity and traceability.,二、创新医疗器械特别审批获得通过，有哪些优惠政策?,II. What are the preferential policies for passing the special approval of innovative medical devices?,申请人所在地食品药品监督管理部门应当指定专人，
8、应申请人的要求及时沟通、提供指导。在接到申请人质量管理体系检查（考核）申请后，应当予以优先办理。,The local food and drug supervision and administration authority shall 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) appli
9、cation, should be given priority.,医疗器械检测机构在进行注册检测时，应当及时对生产企业提交的产品标准或技术要求进行预评价，对存在问题的，应当及时向生产企业提出修改建议。,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 o
10、f the companies, shall be timely proposed amendments.,医疗器械检测机构应当在接受样品后优先进行医疗器械注册检测，并出具检测报告。,Testing institution for medical devices shall make a registration test for medical devices in priority after accepting samples , and issue the report.,创新医疗器械的临床试验应当按照医疗器械临床试验相关规定的要求进行，食品药品监督管理部门应当根据临床试验的进程进行监
11、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 according to the process of clinical trials.
12、,在产品注册申请受理前以及技术审评过程中，食品药品监管总局医疗器械技术审评中心应当指定专人，应申请人的要求及时沟通、提供指导，共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, Center for Medical Device Evaluation of SFDA shall designate someone, at the request of the applicant, provide guidance f
13、or timely communication and discuss the related technical problems.,企业可以通过申请与审评中心指定专人就以下问题进行沟通交流：1. 重大技术问题；2. 重大安全性问题；3. 临床试验方案：4. 阶段性临床试验结果的总结与评价；5. 其他需要沟通交流的重要问题。,Enterprises can apply for communicating with designated person of Evaluation Center on the following issues:1. Major technical problems
14、;2. Major safety issues;3. Clinical trial schemes;4. Periodic summary andevaluation of the resultsof clinical trials;5. The other importantissues that need tocommunicate.,受理创新医疗器械注册申请后，应当将该注册申请项目标记为“创新医疗器械”，并及时进行注册申报资料流转。,After accepting the application for registration of innovative medical devices
15、, the registration items shall be marked as “innovative medical devices“, and register to declare information flow in a timely manner.,已受理注册申报的创新医疗器械，食品药品监管总局医疗器械技术审评中心应当优先进行技术审评；技术审评结束后，食品药品监管总局优先进行行政审批。,For the innovative medical devices that have been declared to accept the registration, Center f
16、or Medical Devices Evaluation, SFDA should give priority to the technical review; after the technical evaluation, SFDA is priority to administrative approval.,三、申报创新医疗器械特别审批应准备哪些资料?,III. What information should be ready for declaring the special approval of innovative medical devices?,1.申请人企业法人资格证明文件；2.产品知识产权情况及证明文件；3.产品研发过程及结果的综述；,1.Legal person qualification certificates of the applicant;2.Intellectual property information and supporting documents of products;3.Summary of product development process and results;,
