医疗器械注册管理办法(2014) Measures for the Administration of Registration of Medical Devices (2014)

 
Order of the China Food and Drug Administration 国家食品药品监督管理总局令
(No. 4) (第4号)
The Measures for the Administration of Registration of Medical Devices, as deliberated and adopted at the executive meeting of the China Food and Drug Administration on June 27, 2014, are hereby issued, and come into force on October 1, 2014. 医疗器械注册管理办法》已于2014年6月27日经国家食品药品监督管理总局局务会议审议通过,现予公布,自2014年10月1日起施行。
Director: Zhang Yong 局 长  张勇
July 30, 2014 2014年7月30日
Measures for the Administration of Registration of Medical Devices 医疗器械注册管理办法
 
Chapter I General Provisions 第一章 总 则
Article 1 To regulate the administration of registration and recordation of medical devices, and ensure the safety and utility of medical devices, these Measures are developed in accordance with the Regulation on the Supervision and Administration of Medical Devices.   第一条 为规范医疗器械的注册与备案管理,保证医疗器械的安全、有效,根据《医疗器械监督管理条例》,制定本办法。
Article 2 Whoever sells or uses medical devices within the territory of the People’s Republic of China shall apply for registration or undergo recordation in accordance with these Measures.   第二条 在中华人民共和国境内销售、使用的医疗器械,应当按照本办法的规定申请注册或者办理备案。
Article 3 Medical device registration means the process whereby the food and drug administrative departments, upon the application of the medical device registration applicants, carry out systematic evaluation on the safety and utility research of the medical devices to be marketed and on the research results thereof in accordance with the legal procedure, so as to decide whether to approve their registration.   第三条 医疗器械注册是食品药品监督管理部门根据医疗器械注册申请人的申请,依照法定程序,对其拟上市医疗器械的安全性、有效性研究及其结果进行系统评价,以决定是否同意其申请的过程。
Medical device recordation means the process whereby the parties undergoing recordation of medical devices submit recordation materials to the food and drug administrative departments and the food and drug administrative departments put such materials on file for future reference. 医疗器械备案是医疗器械备案人向食品药品监督管理部门提交备案资料,食品药品监督管理部门对提交的备案资料存档备查。
Article 4 The principles of openness, equity and fairness shall be followed in the registration and recordation of medical devices.   第四条 医疗器械注册与备案应当遵循公开、公平、公正的原则。
Article 5 Medical devices of Class I are subject to recordation administration, while medical devices of Class II and Class III are subject to registration administration.   第五条 第一类医疗器械实行备案管理。第二类、第三类医疗器械实行注册管理。
For domestic medical devices of Class I, the parties undergoing recordation shall submit recordation materials to the food and drug administrative departments at the city level. 境内第一类医疗器械备案,备案人向设区的市级食品药品监督管理部门提交备案资料。
For domestic medical devices of Class II, the food and drug administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for examination, and shall issue registration certificates for medical devices in the case of approval. 境内第二类医疗器械由省、自治区、直辖市食品药品监督管理部门审查,批准后发给医疗器械注册证。
For domestic medical devices of Class III, the China Food and Drug Administration (“CFDA”) shall be responsible for examination, and shall issue registration certificates for medical devices in the case of approval. 境内第三类医疗器械由国家食品药品监督管理总局审查,批准后发给医疗器械注册证。
For imported medical devices of Class I, the parties undergoing recordation shall submit recordation materials to the CFDA. 进口第一类医疗器械备案,备案人向国家食品药品监督管理总局提交备案资料。
For imported medical devices of Class II or III, the CFDA shall be responsible for examination, and shall issue registration certificates for medical devices in the case of approval. 进口第二类、第三类医疗器械由国家食品药品监督管理总局审查,批准后发给医疗器械注册证。
The registration or recordation of medical devices from Hong Kong, Macao and Taiwan shall be governed by reference with the provisions governing imported medical devices. 香港、澳门、台湾地区医疗器械的注册、备案,参照进口医疗器械办理。
Article 6 Where the parties applying for registration or undergoing recordation of medical devices market such products in their own names, they shall assume legal responsibilities for the products.   第六条 医疗器械注册人、备案人以自己名义把产品推向市场,对产品负法律责任。
Article 7 The food and drug administrative departments shall timely disclose information about the registration and recordation of medical devices according to the law. Applicants may check the examination progress and result, and the public shall have access to the examination result.   第七条 食品药品监督管理部门依法及时公布医疗器械注册、备案相关信息。申请人可以查询审批进度和结果,公众可以查阅审批结果。
Article 8 The state encourages the research and innovation of medical devices, subjects innovative medical devices to special approval, promotes the popularization and application of new technologies for medical devices, and enhances the development of the medical device industry.   第八条 国家鼓励医疗器械的研究与创新,对创新医疗器械实行特别审批,促进医疗器械新技术的推广与应用,推动医疗器械产业的发展。
 
Chapter II Basic Requirements 第二章 基本要求
Article 9 The parties applying for registration or undergoing recordation of medical devices shall establish quality management systems for the research, development and manufacturing of products, and maintain their efficiency.   第九条 医疗器械注册申请人和备案人应当建立与产品研制、生产有关的质量管理体系,并保持有效运行。
Where a party applies for registration of a domestic medical device subject to approval by the special approval procedure for innovative medical devices, if it commissions another enterprise to manufacture the sample, it shall select a medical device manufacturing enterprise whose scope of manufacturing covers the product. A party that applies for registration of a domestic medical device not subject to approval by the special approval procedure for innovative medical devices may not commission another enterprise to manufacture the sample. 按照创新医疗器械特别审批程序审批的境内医疗器械申请注册时,样品委托其他企业生产的,应当委托具有相应生产范围的医疗器械生产企业;不属于按照创新医疗器械特别审批程序审批的境内医疗器械申请注册时,样品不得委托其他企业生产。
Article 10 Personnel responsible for handling matters concerning the registration or recordation of medical devices shall have corresponding professional knowledge, and be familiar with laws, regulations, rules and technical requirements on the registration or recordation administration of medical devices.   第十条 办理医疗器械注册或者备案事务的人员应当具有相应的专业知识,熟悉医疗器械注册或者备案管理的法律、法规、规章和技术要求。
Article 11 The parties applying for registration or undergoing recordation of medical devices shall follow the basic requirements on the safety and utility of medical devices, and ensure that the research and development process meet the relevant requirements and that all data is true, integrated and traceable.   第十一条 申请人或者备案人申请注册或者办理备案,应当遵循医疗器械安全有效基本要求,保证研制过程规范,所有数据真实、完整和可溯源。
Article 12 The registration application materials or recordation materials shall be prepared in Chinese. If they are translated from foreign materials, the originals shall be also provided. Where the cited documentary materials have not been published, a certificate of permission granted by the owner of such materials shall be provided.   第十二条 申请注册或者办理备案的资料应当使用中文。根据外文资料翻译的,应当同时提供原文。引用未公开发表的文献资料时,应当提供资料所有者许可使用的证明文件。
The parties applying for registration or undergoing recordation of medical devices shall be responsible for the truthfulness of the materials they submit. 申请人、备案人对资料的真实性负责。
Article 13 An imported medical device to be registered or granted recordation shall have been approved for sale on the market in the country (or region) of the place of registration of the party applying for its registration or undergoing its recordation or its manufacturing country (or region).   第十三条 申请注册或者办理备案的进口医疗器械,应当在申请人或者备案人注册地或者生产地址所在国家(地区)已获准上市销售。
If the product is not treated as a medical device in the country (or region) of the place of registration of the party applying for its registration or undergoing its recordation or its manufacturing country (or region), the party applying for its registration or undergoing its recordation shall provide relevant certification documents, including a document approving the sale of the product on the market in the country (or region) of the place of registration of the party applying for its registration or undergoing its recordation or its manufacturing country (or region). 申请人或者备案人注册地或者生产地址所在国家(地区)未将该产品作为医疗器械管理的,申请人或者备案人需提供相关证明文件,包括注册地或者生产地址所在国家(地区)准许该产品上市销售的证明文件。
Article 14 For an overseas party applying for registration or undergoing recordation, its representative office in China or an enterprise legal person in China designated by it as its agent shall assist it in handling the relevant matters.   第十四条 境外申请人或者备案人应当通过其在中国境内设立的代表机构或者指定中国境内的企业法人作为代理人,配合境外申请人或者备案人开展相关工作。
In addition to handling matters concerning the registration or recordation of medical devices, an agent shall also be responsible for: 代理人除办理医疗器械注册或者备案事宜外,还应当承担以下责任:
(1) contacting the competent food and drug administrative department and the overseas party applying for registration or undergoing recordation that it represents; (一)与相应食品药品监督管理部门、境外申请人或者备案人的联络;
(2) truthfully and accurately informing the party applying for registration or undergoing recordation of the relevant laws, regulations and technical requirements; (二)向申请人或者备案人如实、准确传达相关的法规和技术要求;
(3) gathering information about any adverse event occurs after the medical device is put on the market, informing the party applying for registration or undergoing recordation of it, and reporting it to the competent food and drug administrative department; (三)收集上市后医疗器械不良事件信息并反馈境外注册人或者备案人,同时向相应的食品药品监督管理部门报告;
(4) coordinating the recall of products after the medical device is put on the market, and reporting the relevant information to the competent food and drug administrative department; and (四)协调医疗器械上市后的产品召回工作,并向相应的食品药品监督管理部门报告;
(5) bearing any other joint and several liability concerning the quality and after-sale service of products. (五)其他涉及产品质量和售后服务的连带责任。
 
Chapter III Technical Requirements and Registration Testing 第三章 产品技术要求和注册检验
Article 15 A party applying for registration or undergoing recordation of a medical device shall prepare the technical requirements for the medical device. The technical requirements for a medical device of Class I shall be submitted to the food and drug administrative department by the party undergoing its recordation at the time when undergoing the recordation procedure. The technical requirements for a medical device of Class II or III shall be subject to the confirmation of the food and drug administrative department at the time when the department approves its registration.   第十五条 申请人或者备案人应当编制拟注册或者备案医疗器械的产品技术要求。第一类医疗器械的产品技术要求由备案人办理备案时提交食品药品监督管理部门。第二类、第三类医疗器械的产品技术要求由食品药品监督管理部门在批准注册时予以核准。
The technical requirements for a medical device mainly comprise the performance indicators and inspection methods for the finished products of the medical device. In particular, performance indicators mean indicators which may be used to objectively assess the performance and safety of finished products, and other indicators related to quality control. 产品技术要求主要包括医疗器械成品的性能指标和检验方法,其中性能指标是指可进行客观判定的成品的功能性、安全性指标以及与质量控制相关的其他指标。
Medical devices on the market of China shall comply with the technical requirements that have been confirmed upon registration or that have been granted recordation. 在中国上市的医疗器械应当符合经注册核准或者备案的产品技术要求。
Article 16 A medical device to be registered into Class II or III shall be subject to registration testing. Medical device testing institutions shall conduct registration testing on the relevant products according to the technical requirements for such products.   第十六条 申请第二类、第三类医疗器械注册,应当进行注册检验。医疗器械检验机构应当依据产品技术要求对相关产品进行注册检验。
The production of samples for registration testing shall comply with the relevant requirements of the medical device quality management system. Medical devices are available for clinical trial or registration only after they have passed registration testing. 注册检验样品的生产应当符合医疗器械质量管理体系的相关要求,注册检验合格的方可进行临床试验或者申请注册。
Parties undergoing recordation of medical devices of Class I may submit self-testing reports on the devices. 办理第一类医疗器械备案的,备案人可以提交产品自检报告。
Article 17 An applicant for registration testing shall provide the testing institution with the relevant technical materials, the samples for testing, and the technical requirements for the product concerned, as required for testing.   第十七条 申请注册检验,申请人应当向检验机构提供注册检验所需要的有关技术资料、注册检验用样品及产品技术要求。
Article 18 Medical device testing institutions shall be qualified for medical device testing, conduct testing within their scope of business, and pre-evaluate the technical requirements submitted by the applicants. The pre-evaluation opinions shall be issued to the applicants together with the registration testing reports.   第十八条 医疗器械检验机构应当具有医疗器械检验资质、在其承检范围内进行检验,并对申请人提交的产品技术要求进行预评价。预评价意见随注册检验报告一同出具给申请人。
The testing of medical devices that have not been included in the scope of business of medical device testing institutions shall be conducted by capable testing institutions designated by the departments approving the registration of such devices. 尚未列入医疗器械检验机构承检范围的医疗器械,由相应的注册审批部门指定有能力的检验机构进行检验。
Article 19 The products tested within one registration unit shall be the typical products which can represent the safety and utility of other products within this registration unit.   第十九条 同一注册单元内所检验的产品应当能够代表本注册单元内其他产品的安全性和有效性。
 
Chapter IV Clinical Evaluation 第四章 临床评价
Article 20 The clinical evaluation of a medical device means the process whereby the party applying for registration or undergoing recordation of the medical device confirms whether the product meets the operating requirements or scope of application based on the clinical documentation, clinical experience, clinical trials, and other clinical data.   第二十条 医疗器械临床评价是指申请人或者备案人通过临床文献资料、临床经验数据、临床试验等信息对产品是否满足使用要求或者适用范围进行确认的过程。
Article 21 Clinical evaluation documents mean the documents formed in the clinical evaluation conducted by the party applying for registration or undergoing recordation of a medical device.   第二十一条 临床评价资料是指申请人或者备案人进行临床评价所形成的文件。
If clinical trials are required, the clinical evaluation documents to be submitted shall include the clinical trial plan and the clinical trial report. 需要进行临床试验的,提交的临床评价资料应当包括临床试验方案和临床试验报告。
Article 22 Clinical trials are not required for the recordation of a medical device of Class I, but are required for the registration of a medical device of Class II or III.   第二十二条 办理第一类医疗器械备案,不需进行临床试验。申请第二类、第三类医疗器械注册,应当进行临床试验。
Under any of the following circumstances, medical devices may be exempt from clinical trials: 有下列情形之一的,可以免于进行临床试验:
(1) They have clear and definite working mechanisms, finalized designs and mature manufacturing techniques, the marketed medical devices of the same category have been put into clinical application for years with no record of severe adverse event, and their general purposes remain unchanged. (一)工作机理明确、设计定型,生产工艺成熟,已上市的同品种医疗器械临床应用多年且无严重不良事件记录,不改变常规用途的;
(2) The safety and utility of such medical devices can be proved through non-clinical evaluation. (二)通过非临床评价能够证明该医疗器械安全、有效的;
(3) The safety and utility of such medical devices can be proved through the analysis and evaluation of the data obtained from the clinical trials or clinical application of medical devices of the same category. (三)通过对同品种医疗器械临床试验或者临床使用获得的数据进行分析评价,能够证明该医疗器械安全、有效的。
The catalogue of medical devices exempt from clinical trials shall be established, adjusted and published by the CFDA. For products not included in the catalogue of medical devices exempt from clinical trials, if their safety and utility can be proved through the analysis and evaluation of the data obtained from the clinical trials or clinical application of medical devices of the same category, the parties applying for their registration may state the facts, and provide the relevant certification documents. 免于进行临床试验的医疗器械目录由国家食品药品监督管理总局制定、调整并公布。未列入免于进行临床试验的医疗器械目录的产品,通过对同品种医疗器械临床试验或者临床使用获得的数据进行分析评价,能够证明该医疗器械安全、有效的,申请人可以在申报注册时予以说明,并提交相关证明资料。
Article 23 The clinical trials of medical devices shall be conducted in qualified clinical trial institutions in accordance with the requirements of the quality control criteria for the clinical trials of medical devices. The manufacturing of samples for clinical trials shall comply with the relevant requirements of the medical device quality management system.   第二十三条 开展医疗器械临床试验,应当按照医疗器械临床试验质量管理规范的要求,在取得资质的临床试验机构内进行。临床试验样品的生产应当符合医疗器械质量管理体系的相关要求。
Article 24 The clinical trials of medical devices of Class III which may pose relatively high risks to human bodies shall be subject to the approval of the CFDA. The catalogue of medical devices of Class III subject to approval for clinical trials shall be established, adjusted and published by the CFDA.   第二十四条 第三类医疗器械进行临床试验对人体具有较高风险的,应当经国家食品药品监督管理总局批准。需进行临床试验审批的第三类医疗器械目录由国家食品药品监督管理总局制定、调整并公布。
Article 25 The approval of clinical trials means the process whereby the CFDA, upon the application of applicants, comprehensively analyzes the degree of risks in the medical devices to be put in clinical trials, the clinical trial plans, and the clinical benefit and risk comparison and analysis reports to decide whether to approve the clinical trials of the medical devices.   第二十五条 临床试验审批是指国家食品药品监督管理总局根据申请人的申请,对拟开展临床试验的医疗器械的风险程度、临床试验方案、临床受益与风险对比分析报告等进行综合分析,以决定是否同意开展临床试验的过程。
Article 26 To apply for approval of the clinical trials of medical devices, the applicants shall file application materials with the CFDA in accordance with the relevant requirements.   第二十六条 需进行医疗器械临床试验审批的,申请人应当按照相关要求向国家食品药品监督管理总局报送申报资料。
Article 27 The CFDA shall, within three working days after accepting an application for the clinical trials of a medical device, transfer the application materials to its medical device technical evaluation institution.   第二十七条 国家食品药品监督管理总局受理医疗器械临床试验审批申请后,应当自受理申请之日起3个工作日内将申报资料转交医疗器械技术审评机构。
The technical evaluation institution shall complete technical evaluation within 40 working days. The CFDA shall make a decision of approval or disapproval within 20 working days upon the completion of technical evaluation. In the case of approval, it shall issue a clinical trial approval document; in the case of disapproval, it shall explain the reasons in writing. 技术审评机构应当在40个工作日内完成技术审评。国家食品药品监督管理总局应当在技术审评结束后20个工作日内作出决定。准予开展临床试验的,发给医疗器械临床试验批件;不予批准的,应当书面说明理由。
Article 28 Where the technical evaluation institution requires the applicant to supplement or correct application materials in the course of technical evaluation, it shall notify the applicant at one time of all contents that need to be supplemented or corrected. The applicant shall provide supplementary materials required in the supplement or correction notice at one time within one year. The technical evaluation institution shall complete technical evaluation within 40 working days upon receipt of the supplementary materials. The time needed by the applicant for submitting supplementary materials is not included in the time limit for evaluation.   第二十八条 技术审评过程中需要申请人补正资料的,技术审评机构应当一次告知需要补正的全部内容。申请人应当在1年内按照补正通知的要求一次提供补充资料。技术审评机构应当自收到补充资料之日起40个工作日内完成技术审评。申请人补充资料的时间不计算在审评时限内。