中国创新医疗器械特别审批程序介绍顾汉卿

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 science 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 StateFoodandDrugAdministration (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 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 lawthrough the transfereeobtain the patent right forinventionorthe 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 mainworking principle/mechanism of products are the first in the country. 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 significantvalue 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 preliminary research of the product and finalized the designed product. The process of study is real and controlled, with dataintegrityand 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 thepreferential 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，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 fortimely 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 problemsof 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。,Testinginstitution for medical devices shallmake a registrationtest formedical devices in priority after acceptingsamples,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督检查。,Clinical trials of innovative medical devices shall be in accordance with the requirements ofrelated 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.,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 MedicalDevice Evaluationof SFDA shall designate someone, at the request of the applicant,provide guidance fortimely 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 EvaluationCenter on the following issues: 1. Major technical problems; 2. Major safety issues; 3. Clinical trial schemes; 4. Periodic summary and evaluation of the results of clinical trials; 5. The other important issues thatneed to communicate.,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, 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 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.Legalpersonqualificationcertificatesofthe applicant; 2.Intellectual property information and supporting documents of products; 3.Summary of product development process and results;,4.产品技术文 件，至少应当 包括： 产品的预期用 途； 产品工作原理/ 作用机理；,4.Technical documents of products should include at least 1) The intended use of products; 2) The working principle and mechanismofproducts;,产品主要技术指标及确定依据，主要原材料、关键元器件的指标要求，主要生产工艺过程及流程图，主要技术指标的检验方法。,3) The main technical indicators and basis of products, the main raw materials, the index requirements of key components, the main productionprocessand flow chart, and the testing method of main technical indicators.,5.产品创新的证明性文件，至少应当包括：信息或者专利检索机构出具的查新报告；核心刊物公开发表的能够充分说明产品临床应用价值的学术论文、专著及文件综述；,5. Documented evidence of product innovation include at least 1) The testing report issuedby information or patent search agency; 2) Academic papers, monographs anddocumentsreview published in core journals that can fully explain the clinical application value.,国内外已上市同类产品应用情况的分析及对比（如有）；产品的创新内容及在临床应用的显著价值。,3) Analysis and comparison in the application of similar products already listed on the market at home and abroad (if any); 4)The innovation content ofproducts andsignificantvalueinclinical application.,6.产品安全风险管理报告。 7.产品说明书。 8.其他证明产品符合创新医疗器械要求的资料。,6. A report on safetyand risk management of products. 7. Product Manual. 8. Other supporting information that can prove to meet therequirements ofinnovativemedical devices.,9.境外申请人应当委托中国境内的企业法人作为代理人或者由其在中国境内的办事机构提出申请，并提交以下文件：,9.An overseas applicant shall entrust a legal person of enterprise in China as an agent or by its offices in China, apply for and submit the following documents:,境外申请人委托代理人或者其在中国境内办事机构办理创新医疗器械特别审批申请的委托书；,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.,代理人或者申请人在中国境内办事机构的承诺书； 代理人营业执照或者申请人在中国境内办事机构的机构登记证明。,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.所提交资料真实性的自我保证声明。11.申报资料应当使用中文。原文为外文的，应当有中文译本。,10.Self-declarationbytheenterprisetoguaranteethetruthfulness ofthedocumentation submitted. 11.Alldocumentsrequiredto besubmittedbyanapplicant shallbeinChinese; iftheoriginaldocumentisinaforeignlanguage,aChinese translationshallbeprovided.,境内申请人应当向其所在地的省级食品药品监督管理部门提出创新医疗器械特别审批申请，当局于20个工作日内出具初审意见。报送国家食品药品监督管理局。,A domestic applicant shall apply for special approval of innovative medicaldevices to the local provincial food and drug supervision and administration department. And the authorities will issue a preliminary examination opinion within 20 working days, submitting to SFDA.,境外申请人应当向食品药品监管总局提出创新医疗器械特别审查，对符合本程序第四条规定的形式要求的予以受理。,An overseas applicant shall apply for special approval of innovative medicaldevices to SFDA, which will be accepted in compliance with the provisions of Article IV.,食品药品监管总局医疗器械技术审评中心设立创新医疗器械审查办公室，授权中国生物医学工程学会负责对创新医疗器械特别审批申请进行审查，并于受理后40个工作日内出具审查意见。,Center for 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公室审查，对拟进行特别审批的申请项目，在食品药品监管总局医疗器械技术审评中心网站将申请人、产品名称予以公示，公示时间应当不少于10个工作日。对于有异议的，应当对相关意见研究后作出最终审查决定。,Reviewed by the Office for Innovative Medical Devices, for the proposed application on special approval, announce to the applicant and the product name in the website of Center for Medical Devices Evaluation of SFDA，publicity timeshall not beless than 10 working days. For any objection, it shall, after advice to related research, make a decision on the final review.,创新医疗器械审查办公室作出审查决定后，将审查结果书面通知申请人，对境内企业的申请，同时抄送申请人所在地省级食品药品监督管理部门。,After reviewing by the Office of Innovative Medical Devic