2014 年 02 月 07 日发布 Released on February 7, 2014 各省 自治区 直辖市食品药品监督管理局 : To the Food and Drug Administrations of various provinces, autonomous regions an

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1 食品药品监管总局关于印发创新医疗器械特别审批程序 ( 试行 ) 的通知 Food and Drug Administration Notice Regarding the Issuance of Special Examination and Approval Procedures for Innovative Medical Products (Trial) 食药监械管 号 Shi Yao Jian Xia Guan 2014 Number 13 PRESENTED BY: Tad Ferris Partner Foley & Lardner LLP tferris@foley.com Foley & Lardner LLP Attorney Advertisement Prior results do not guarantee a similar outcome 321 North Clark Street, Chicago, IL

2 2014 年 02 月 07 日发布 Released on February 7, 2014 各省 自治区 直辖市食品药品监督管理局 : To the Food and Drug Administrations of various provinces, autonomous regions and municipalities under the direct jurisdiction of the central government: 为了保障医疗器械的安全 有效, 鼓励医疗器械的研究与创新, 促进医疗器械新技术的推广和应用, 推动医疗器械产业发展, 总局组织制定了 创新医疗器械特别审批程序 ( 试行 ), 现印发给你们, 请遵照执行 To safeguard the safety and effectiveness of medical devices, encourage research and innovations in medical devices and promote the popularization and application of new technologies in medical devices, the Administration has organized the preparation of Special Examination and Approval Procedures for Innovative Medical Devices (Trial), which are hereby issued to you. Please comply with and implement the same. 国家食品药品监督管理总局 China Food and Drug Administration 2014 年 2 月 7 日 February 7, 2014 创新医疗器械特别审批程序 ( 试行 ) Special Examination and Approval Procedures for Innovative Medical Devices (Trial) 第一条为了保障医疗器械的安全 有效, 鼓励医疗器械的研究与创新, 促进医疗器械新技术的推广和应用, 推动医疗器械产业发展, 根据 医疗器械监督管理条例 医疗器械注册管理办法 等法规和规章, 制定本程序 Article 1 To safeguard the safety and effectiveness of medical devices, encourage research and innovations in medical devices and promote the popularization and application of new technologies in medical devices, in accordance with laws and regulations including Regulations on the Supervision and Management of Medical Devices and Measures for the Registration and Management of Medical Devices, these Procedures are hereby developed. 第二条食品药品监督管理部门对同时符合下列情形的医疗器械按本程序实施审评审批 : Article 2 Food and drug supervision and management authorities shall implement examinations, evaluations and approval of medical devices that concurrently meet the following conditions:

3 ( 一 ) 申请人经过其技术创新活动, 在中国依法拥有产品核心技术发明专利权, 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 (I) Through its technological innovation activities, an applicant owns patent rights in China in accordance with law for the core technology of its product, or has acquired the patent rights or related use rights in China through a transfer in accordance with law; or the patent application for such core technology has been published by the patent administration authorities of the State Council. ( 二 ) 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, 并且具有显著的临床应用价值 (II) The primary working principles/mechanism of the product are first created in China. Compared with similar products, the performance or safety of the product has been fundamentally improved. Technologically, it is at a leading international level and has a significant clinical application value. ( 三 ) 申请人已完成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 (III) The applicant has completed the preliminary research on the product and has a basically approved product. The research process is truthful and controlled. The research data is complete and traceable. 第三条各级食品药品监督管理部门及相关技术机构, 根据各自职责和本程序规定, 按照早期介入 专人负责 科学审批的原则, 在标准不降低 程序不减少的前提下, 对创新医疗器械予以优先办理, 并加强与申请人的沟通交流 Article 3 Food and drug supervision and management authorities at various levels and the relevant technical agencies shall, in accordance with their duties and the provisions of these Procedures and the principle of early intervention, having dedicated persons in charge and conducting scientific examination and approval, handle innovative medical devices on a priority basis without lowering the standards and reducing the procedures and shall enhance communications and exchange with the applicant. 第四条申请人申请创新医疗器械特别审批, 应当填写 创新医疗器械特别审批申请表 ( 见附件 1), 并提交支持拟申请产品符合本程序第二条要求的资料 资料应当包括 : 2

4 Article 4 An applicant applying for special examination and approval of an innovative medical device shall complete Application Form for Special Examination and Approval of an Innovative Device (see Attachment 1) and shall submit materials showing compliance of the product proposed for application with the requirements of Article 2 of these Procedures. Such materials shall include: ( 一 ) 申请人企业法人资格证明文件 (I) Documents proving the corporate legal person qualifications of the applicant. ( 二 ) 产品知识产权情况及证明文件 (II) Information and the proof documents of the intellectual property rights of the product. ( 三 ) 产品研发过程及结果的综述 (III) A summary of the research and development process and result of the product. ( 四 ) 产品技术文件, 至少应当包括 : (IV) Technical documents of the product, which shall at least include: 1. 产品的预期用途 ; 1. the intended use of the product; 2. 产品工作原理 / 作用机理 ; 2. the working principles/mechanism of the product; 3. 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. major technical indexes of the product and the basis for determining them; the index requirements of major raw materials and key components; major production processes and flow charts and the inspection methods of major technical indexes. ( 五 ) 产品创新的证明性文件, 至少应当包括 : (V) Evidentiary documents of product innovations, which at least shall include: 1. 信息或者专利检索机构出具的查新报告 ; 1. new product search reports issued by information or patent retrieval agencies; 2. 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 ; 3

5 2. academic theses, special works and document summaries published in major magazines capable of fully explaining the clinical application value of the product; 3. 国内外已上市同类产品应用情况的分析及对比 ( 如有 ; 3. analyses of an comparisons with applications of similar products, if any, already marketed at home and abroad; and 4. 产品的创新内容及在临床应用的显著价值 4. innovative contents of the product and the significant value in clinical applications. ( 六 ) 产品安全风险管理报告 (VI) A product safety risk management report. ( 七 ) 产品说明书 ( 样稿 ) (VII) Product specifications (sample draft). ( 八 ) 其他证明产品符合本程序第二条的资料 (VIII) Other materials proving compliance of the product with Article 2 of these Procedures. ( 九 ) 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 : (IX) An applicant outside of China shall authorize a corporate person in China as its agent or its offices/branches in China to file an application and shall submit the following documents: 1. 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. A power of attorney of such an applicant overseas to authorize an agent or its offices/branchesin China to handle the application for the special examination and approval of an innovative medical device; 2. 代理人或者申请人在中国境内办事机构的承诺书 ; 2. A commitment letter from such an agent or applicant s office/branch; and 3. 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 3. The business license of such an agent or proof of registration of the office/branch of the applicant in China. 4

6 ( 十 ) 所提交资料真实性的自我保证声明 申报资料应当使用中文 原文为外文的, 应当有中文译本 (X) A self declaration guaranteeing the truthfulness of the materials submitted. The application materials shall be in Chinese. If the original text is in a foreign language, there shall be a Chinese translation. 第五条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 省级食品药品监督管理部门对申报项目是否符合本程序第二条要求进行初审, 并于 20 个工作日内出具初审意见 经初审不符合第二条要求的, 省级食品药品监督管理部门应当通知申请人 ; 符合第二条要求的, 省级食品药品监督管理部门将申报资料和初审意见一并报送国家食品药品监督管理总局 ( 以下简称食品药品监管总局 ) 行政受理服务中心 Article 5 A domestic applicant shall submit an application for special examination and approval of an innovative medical device with the local provincial level food and drug supervision and management authorities. The provincial level food and drug supervision and management authorities shall perform an initial examination in accordance with the requirements of Article 2 of these Procedures and shall submit an initial examination opinion within 20 business days. In the event that the requirements of Article 2 are not met, the provincial level food and drug supervision and management authorities shall notify the applicant; in the event that the requirements of Article 2 are met, the provincial level food and drug supervision and management authorities shall forward the application materials together with the initial examination opinion to the China Food and Drug Administration (hereinafter referred to as the CFDA) administrative acceptance service center. 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批申请, 食品药品监管总局行政受理服务中心对申报资料进行形式审查, 对符合本程序第四条规定的形式要求的予以受理 An overseas applicants shall submit an application for special examination and approval of an innovative medical device with the CFDA. The CFDA administrative acceptance service center shall perform a formality examination of the application materials and shall accept those that have met the formality requirements specified in Article 4 of these Procedures. 第六条食品药品监管总局行政受理服务中心对受理的特别审批申请, 给予产品特别审批申请受 理编号, 受理编号编排方式为 : 械特 - 2, 其中 为申请的年份 ; 为产品 流水号 Article 6 In the event that a special examination and approval application has been accepted, the CFDA administrative acceptance service center shall assign it a product special examination and approval application acceptance number. The acceptance number formatting method shall be: Xie Te Fu 1- Fu 2, where Fu 1 shall be the year of application and Fu 2 shall be the product serial number. 5

7 第七条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 ( 以下简称创新医疗器械审查办公室 ), 对创新医疗器械特别审批申请进行审查 Article 7 The CFDA medical device technology examination and evaluation center shall set up an innovative medical device examination office (hereinafter referred to as the innovative medical device examination office), to perform examinations of applications for special examination and approval of innovative medical devices. 第八条食品药品监管总局受理创新医疗器械特别审批申请后, 由创新医疗器械审查办公室组织专家进行审查, 并于受理后 40 个工作日内出具审查意见 Article 8 After the CFDA accepts an application for special examination and approval of an innovative medical device, the innovative medical device examination office shall organize experts for an examination and shall issue an examination opinion within 40 business days after the acceptance of the application. 第九条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, 应当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 对于公示有异议的, 应当对相关意见研究后作出最终审查决定 Article 9 Upon an examination by the innovative medical device examination office, with regard to intended approval for the application, the applicant and product name shall be made public on the website of the CFDA medical device examination and evaluation center. The duration of such publicity shall be no less than 10 business days. In case of any objections to such a publication, a final examination decision shall be made after studying the relevant opinion. 第十条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 ( 格式见附件 2) Article 10 After the innovative medical device examination office makes an examination decision, it shall notify the applicant of the examination result in writing. In the case of a domestic enterprise application, the local provincial level food and drug supervision and management authorities shall be copied on at the same time (for the format, see Attachment 2). 第十一条创新医疗器械审查办公室在审查创新医疗器械特别审批申请时一并对医疗器械管理类别进行界定 对于境内企业申请, 如产品被界定为第二类或第一类医疗器械, 相应的省级或者设区市级食品药品监督管理部门可参照本程序进行后续工作和审评审批 6

8 Article 11 When examining an application for special examination and approval of an innovative medical device, the innovative medical device examination office shall also define the class of the medical device in conjunction therewith. In the event that the product application by a domestic enterprise is defined as a class 2 or class 1 medical device, the corresponding provincial level or district or municipal level food and drug supervision and management authorities may perform follow-up work and examination, evaluation and approval by referring to these Procedures. 第十二条对于经审查同意按本程序审批的创新医疗器械, 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 Article 12 In the case of an innovative medical device that has received consent upon examination and that is subject to examination and approval in accordance with these Procedures, the local food and drug supervision and management authorities of the applicant shall designate a dedicated person, who shall communicate and provide guidance in a timely manner in accordance with the requirements of the applicant. Upon receipt of an application from the applicant for a quality management system examination (review), it shall be handled on a priority basis. 第十三条对于创新医疗器械, 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注册产品标准进行预评价, 对存在问题的, 应当及时向生产企业提出修改建议 Article 13 In respect of an innovative medical device, when a medical device test agency performs a registration test thereon, it shall perform a preliminary evaluation of the standards for product registration submitted by the manufacturing enterprise in a timely manner. In case any issue exists, it shall make a modification proposal to the manufacturing enterprise in a timely manner. 第十四条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 经过医疗器械检测机构预评价的注册产品标准和 拟申请注册医疗器械产品标准预评价意见表 应当加盖检测机构印章, 随检测报告一同出具 Article 14 Upon receipt of a sample, the medical device test agency shall perform a medical device registration test as a priority and issue a test report. The standards for product registration and The Preliminary Evaluation Opinion Form on the Standards for the Medical Device Product Proposed for Registration that have been preliminarily evaluated by the medical device test agency shall be affixed with the seal of the test agency and shall be issued together with the test report. 第十五条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 7

9 Article 15 The clinical trial of an innovative medical device shall be performed according to the requirements of the relevant provisions for the clinical trials of medical devices. Food and drug supervision and management authorities shall perform supervision and examination according to the clinical trial processes. 第十六条创新医疗器械临床研究工作需重大变更的, 如临床试验方案修订, 使用方法 规格型号 预期用途 适用范围或人群的调整等, 申请人应当评估变更对医疗器械安全性 有效性和质量可控性的影响 产品主要工作原理或作用机理发生变化的创新医疗器械, 应当按照本审批程序重新申请 Article 16 When the clinical research work of an innovative medical device requires any major change, such as amendment to a clinical trial proposal, method of use, specifications and model numbers, intended use, any adjustment to the scope of application or the target users, etc., the applicant shall evaluate the impact of such a change on the safety, effectiveness and quality controllability of the medical device. In case of any innovative medical device the primary working principles or mechanism of action of which experience any change, a reapplication shall be submitted in accordance with these examination and approval procedures. 第十七条对于创新医疗器械, 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 Article 17 In respect of any innovative medical device, prior to acceptance of an application for product application and during the technological examination and evaluation, the CFDA medical device technological examination and evaluation center shall designate a dedicated person who shall communicate and provide guidance in a timely manner in accordance with the requirements of the applicant and who shall jointly discuss the relevant technical issues. 第十八条对于创新医疗器械, 申请人可填写创新医疗器械沟通交流申请表 ( 见附件 3), 就下列问题向食品药品监管总局医疗器械技术审评中心提出沟通交流申请 : Article 18 In respect of any innovative medical device, the applicant may fill out an innovative medical device communication and exchange application form (see Attachment 3) and submit an application for communication and exchange to the CFDA medical device technological examination and evaluation center with respect to the following issue: ( 一 ) 重大技术问题 ; (I) Major technical issues; ( 二 ) 重大安全性问题 ; 8

10 (II) Major safety issues; ( 三 ) 临床试验方案 ; (III) Clinical trial proposal; ( 四 ) 阶段性临床试验结果的总结与评价 ; (IV) Summary and evaluation of the results of periodic clinical trials; and ( 五 ) 其他需要沟通交流的重要问题 (V) Other important issues where there is a need for communication and exchange. 第十九条食品药品监管总局医疗器械技术审评中心应当对申请人提交的沟通交流申请及相关资料及时进行审核, 并将审核结果通知申请人 ( 见附件 4) 食品药品监管总局医疗器械技术审评中心同意进行沟通交流的, 应当明确告知申请人拟讨论的问题, 与申请人商定沟通交流的形式 时间 地点 参加人员等, 安排与申请人沟通交流 沟通交流应形成记录, 记录需经双方签字确认, 供该产品的后续研究及审评工作参考 Article 19 The CFDA medical device technological examination and evaluation center shall review the communication and exchange application and relevant materials of an applicant in a timely manner and notify the applicant of the result of the review (see Attachment 4). In the event that the CFDA medical device technological examination and evaluation center agrees to engage in communication and exchange, it shall clearly notify the applicant of the issues proposed for discussion, determine the form, date, location and participants for such communication and exchange through consultations with the applicant and arrange for such communication and exchange with the applicant. Records shall be generated for such communication and exchange. Such records shall be signed by the parties for confirmation and used for reference in the follow-up research on and review and evaluation work of such a product. 第二十条食品药品监管总局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 Article 20 After the CFDA accepts an application for registration of an innovative medical device, it shall mark such an application item for registration as an innovative medical device and circulate the registration application materials in a timely manner. 第二十一条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 9

11 Article 21 In respect of an innovative medical device whose registration application has been accepted, the CFDA medical device technological examination and evaluation center shall perform a technological examination and evaluation on a priority basis; and upon completion of such a technological examination and evaluation, the CFDA shall perform an administrative examination and approval on a priority basis. 第二十二条属于下列情形之一的, 食品药品监管总局可终止本程序并告知申请人 : Article 22 Upon the occurrence of any of the following circumstances, the CFDA may terminate these Procedures and notify the applicant: ( 一 ) 申请人主动要求终止的 ; (I) The applicant initiates a request of termination; ( 二 ) 申请人未按规定的时间及要求履行相应义务的 ; (II) The applicant fails to perform the corresponding obligations within the prescribed time frame and according to the relevant requirements; ( 三 ) 申请人提供伪造和虚假资料的 ; (III) The applicant provides forged and false materials; and ( 四 ) 经专家审查会议讨论确定不宜再按照本程序管理的 (IV) It is determined through a discussion at an examination meeting by experts that it is not desirable to perform the administration in accordance with these Procedures. 第二十三条食品药品监管总局在实施本程序过程中, 应当加强与国务院各有关部门的沟通和交流, 及时了解创新医疗器械的研发进展 Article 23 During the implementation of these Procedures, the CFDA shall enhance communication and exchange with relevant authorities of the State Council and stay apprised of the progress in the research and development of innovative medical devices in a timely manner. 第二十四条突发公共卫生事件应急所需医疗器械, 按照 医疗器械应急审批程序 办理 Article 24 Upon the occurrence of any public health emergency that requires medical devices, The Emergency Examination and Approval Procedures for Medical Devices shall be implemented. 第二十五条医疗器械注册管理要求和规定, 本程序未涉及的, 按照 医疗器械注册管理办法 等相关规定执行 10

12 Article 25 For any medical device registration and management requirements and provisions not covered in these Procedures, the relevant provisions of Medical Device Registration Management Measures shall be implemented. 第二十六条本程序自 2014 年 3 月 1 日起施行 Article 26 These Procedures shall be effective on March 1, 附件 : 1. 创新医疗器械特别审批申请表 2. 创新医疗器械特别审批申请审查通知单 3. 创新医疗器械沟通交流申请表 4. 创新医疗器械沟通交流申请回复单 Attachments: 1. Special examination and approval application forms for innovative medical devices 2. Notice of application for special examination of innovative medical devices 3. Innovative medical device communications and exchanges application form 4. Reply form to application for communications and exchanges on innovative medical devices 11

13 附件 1 Attachment 1 创新医疗器械特别审批申请表 创新医疗器械特别审批申请表 ( 境内申请人 ) Special examination and approval application form for innovative medical devices Special examination and approval application form for innovative medical devices (for domestic applicants) 产品名称 Product name 申请人名称 Applicant's name 申请人注册地址 Applicant s Registered address 生产地址 Address of production 受理号 : 械特 1-2 Acceptance number: Xie Te

14 规格 / 型号 Specifications/model number 性能结构及组成 Performance structure and composition 主要工作原理 / 作用机理 Primary working principles/mechanism 预期用途 Intended use 联系人 : 联系电话 : 传真 : 联系地址 : 手机 : Contact person: Contact phone: Fax: Contact address: Cell phone: 申请资料 : Application materials: (Additional pages may be attached.) 备注 : Remarks: 13

15 申请单位 ( 盖章 ): 法定代表人 ( 签字 ): 申请日期 : Applicant (Affix seal): Legal representative (Signature): 初审意见 : Application date: 经初审, 该申请符合 创新医疗器械特别审批程序 ( 试行 ) 相关要求, 同意报国家食品药品监督管理总局进一步审查 日期 : ** 食品药品监督管理局 ( 盖章 ) Opinion after initial examination: Upon an initial examination, this application has met the relevant requirements of Special Examination and Approval Procedures for Innovative Medical Devices (Trial) and consent is hereby given to its submission to the China Food and Drug Administration for further examination. (Affix seal) ** Food and Drug Administration Date: 14

16 创新医疗器械特别审批申请表 ( 境外申请人 ) Special examination and approval application form for innovative medical devices (for overseas applicants). 产品名称 Product name 申请人名称 Applicant's name 申请人注册地址 Applicant s Registered address 生产地址 Address of production 规格 / 型号 Specifications/model number 性能结构及组成 Performance structure and composition 主要工作原理 / 作用机理 Primary working principles/mechanism 受理号 : 械特 1-2 Acceptance number: Xie Te

17 预期用途 Intended use 申请人在中国境内的代理人或办事机构名称 : 联系人 : 联系电话 : 传真 : 联系地址 : 手机 : Name of agent or office/branch of applicant in China: Contact person: Contact phone: Fax: Contact address: Cell phone: 申请资料 : Application materials: ( 可附页 ) (Additional pages may be attached) 16

18 备注 : Remarks: 申请人盖章或签字 : 申请人在中国境内的代理人或办事机构盖章 : 申请人在中国境内的代理人或办事机构负责人 ( 签字 ): 申请日期 : Seal or signature of applicant: Seal of agent or office/branch of applicant in China: Agency or person in charge of office/branch of applicant in China (signature): Date of application: 17

19 附件 2 Attachment 2 创新医疗器械特别审批申请审查通知单 Notice of application for special examination of innovative medical devices : 你单位提出的创新医疗器械特别审批申请 ( 受理号 : ), 产品名称 : 性能结构及组成 : 产品管理类别 : 主要工作原理 / 作用机理 : ( 编号 ) (Number: ) 经审查, 审查结论为 : 同意按照 创新医疗器械特别审批程序 ( 试行 ) 进行审批 18

20 不同意按照 创新医疗器械特别审批程序 ( 试行 ) 进行审批, 理由 : 特此通知 抄送 : 食品药品监督管理局 ( 境内医疗器械 ) 国家食品药品监督管理总局 医疗器械技术审评中心 ( 盖章 ) 日期 : The application submitted by your organization for a special examination and approval of a medical device (acceptance receipt number: ), Product name: Performance structure and composition: Type of product management: Primary working principles/mechanism of action: Upon examination, the conclusion of the examination is: Consent is hereby given to examination and approval in accordance with Special Examination and Approval Procedures for Innovative Medical Devices (Trial). Consent is hereby denied for examination and approval in accordance with Special Examination and Approval Procedures for Innovative Medical Devices (Trial), for the following reasons: Reasons:. Notice hereby given. : 19

21 Cc: Food and Drug Administration (medical devices in China). China Food and Drug Administration Medical Device Technology Examination and Evaluation Center (Affix seal) Date: 20

22 附件 3 Attachment 3 创新医疗器械沟通交流申请表 Innovative medical device communications and exchanges application form 申请人名称 Applicant's name 境外申请人在中国境内的代理人或办事机构名称 Name of agent or office/branch of overseas applicant in China 产品名称 Product name 创新医疗器械特别审批申请审查通知单编号 Notice number of special examination and approval of application for innovative medical device 拟沟通交流的部门 Department proposed for communication and exchange 拟沟通交流的方式 Proposed method of communication and exchange 拟沟通交流的议题 Proposed subject of communication and exchange 目前工作进展的阶段 Current stage of work progress 21

23 沟通交流的相关资料 : Relevant materials for communication and exchange: 申请参加的人员姓名 ( 可附页 ) Name Persons applying to participate (additional pages may be attached) 备注 Remarks 工作单位 Employer 职称 Title ( 可附页 )(Additional pages may be attached) 研究中负责的工作专业 Work responsible for Specialty during research 申请单位 ( 盖章 ) 申请日期 Applicant organization (affix seal) Date of application 联系人 : 联系电话 : 传真 : 联系地址 : 手机 : Contact person: Contact phone: Fax: Contact address: Cell phone: 注 : 申请人提出沟通交流时, 对拟讨论问题应有完整的解决方案或合理的解释依据 Note: The applicant should have a complete solution or reasonable basis of explanation when submitting an application for communication and exchange. 22

24 附件 4 Attachment 4 创新医疗器械沟通交流申请回复单 Reply form to application for communications and exchanges on innovative medical devices 申请人名称 Applicant's name 境外申请人在中国境内的代理人或办事机构名称 Name of agent or agency of overseas applicant in China 产品名称 Product name 创新医疗器械特别审批通知单编号 Notice number of special examination and approval of application for innovative medical device 23

25 沟通交流申请日期 Date of communication and exchange applied for 同意交流的议题或不同意交流的原因 Subject of exchange consented to or reasons for denial of consent to exchange 会议时间 Date of meeting 是否同意 Whether consent will be given 会议地点 Location of meeting 同意交流 不同意交流 Consent is given to the exchange Consent is denied to the exchange 会议资料要求 Requirements for meeting materials 拟参加部门 ( 可附页 ) Department proposed to participate (Additional pages may be attached) 单位及部门 Organization and department ( 可附页 ) (Additional pages may be attached) 人数职责范围 Number 备注 Scope of of Remarks duties persons 24

26 联系方式 Contact information 备注 Remarks 会议联系人 : 联系电话 : 传真 : Contact person for meeting: Fax: Contact phone: 25