医疗器械监督管理条例(2021修订) [现行有效]


Regulation on the Supervision and Administration of Medical Devices (2021 Revision) [Effective]

 
 
Order of the State Council of the People’s Republic of China 中华人民共和国国务院令
(No. 739) (第739号)
The Regulation on the Supervision and Administration of Medical Devices, as revised and adopted at the 119th executive meeting of the State Council on February 21, 2020, is hereby issued and shall come into force on June 1, 2021. 医疗器械监督管理条例》已经2020年12月21日国务院第119次常务会议修订通过,现予公布,自2021年6月1日起施行。
Premier: Li Keqiang 总 理  李克强
February 9, 2021 2021年2月9日
Regulation on the Supervision and Administration of Medical Devices 医疗器械监督管理条例
(Issued by Order No. 276 of the State Council of the People’s Republic of China on January 4, 2000, revised and adopted at the 39th executive meeting of the State Council on February 12, 2014, revised in accordance with the Decision of the State Council to Amend the Regulation on the Supervision and Administration of Medical Devices on May 4, 2017, and revised and adopted at the 119th executive meeting of the State Council on December 21, 2020) (2000年1月4日中华人民共和国国务院令第276号公布 2014年2月12日国务院第39次常务会议修订通过 根据2017年5月4日《国务院关于修改〈医疗器械监督管理条例〉的决定》修订 2020年12月21日国务院第119次常务会议修订通过)
Chapter I General Provisions 第一章 总  则
Article 1 This Regulation is developed for the purposes of ensuring the safety and effectiveness of medical devices, guaranteeing human health and life safety and promoting the development of the medical device industry.   第一条 为了保证医疗器械的安全、有效,保障人体健康和生命安全,促进医疗器械产业发展,制定本条例。
Article 2 Whoever engages in the research and development, production, distribution or use of medical devices as well as the supervision and administration thereof within the territory of the People’s Republic of China shall abide by this Regulation.   第二条 在中华人民共和国境内从事医疗器械的研制、生产、经营、使用活动及其监督管理,适用本条例。
Article 3 The medical products administration of the State Council shall be responsible for the supervision and administration of medical devices nationwide.   第三条 国务院药品监督管理部门负责全国医疗器械监督管理工作。
The relevant departments of the State Council shall be responsible for the supervision and administration related to medical devices within their respective functions. 国务院有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。
Article 4 The local people’s governments at or above the county level shall strengthen the leadership over the supervision and administration of medical devices within their respective administrative regions, organize and coordinate the supervision and administration of medical devices and the emergency response work within their respective administrative regions, strengthen the building of medical device supervision and administration capabilities, and provide guarantees for the safety of medical devices.   第四条 县级以上地方人民政府应当加强对本行政区域的医疗器械监督管理工作的领导,组织协调本行政区域内的医疗器械监督管理工作以及突发事件应对工作,加强医疗器械监督管理能力建设,为医疗器械安全工作提供保障。
The medical products administrations of the local people’s governments at or above the county level shall be responsible for the supervision and administration of medical devices within their respective administrative regions. The relevant departments of the local people’s governments at or above the county level shall be responsible for the supervision and administration related to medical devices within their respective functions. 县级以上地方人民政府负责药品监督管理的部门负责本行政区域的医疗器械监督管理工作。县级以上地方人民政府有关部门在各自的职责范围内负责与医疗器械有关的监督管理工作。
Article 5 Medical device supervision and administration shall follow the principles of risk management, management and control in the whole process, scientific regulation and co-governance by the whole society.   第五条 医疗器械监督管理遵循风险管理、全程管控、科学监管、社会共治的原则。
Article 6 The state shall conduct the classification administration of medical devices according to their risk levels.   第六条 国家对医疗器械按照风险程度实行分类管理。
“Medical devices of Class I” means the medical devices with low risks, whose safety and effectiveness can be ensured through routine administration. 第一类是风险程度低,实行常规管理可以保证其安全、有效的医疗器械。
“Medical devices of Class II” means the medical devices with moderate risks, which shall be strictly controlled and administered to ensure their safety and effectiveness. 第二类是具有中度风险,需要严格控制管理以保证其安全、有效的医疗器械。
“Medical devices of Class III” means the medical devices with relatively high risks, which shall be strictly controlled and administered through special measures to ensure their safety and effectiveness. 第三类是具有较高风险,需要采取特别措施严格控制管理以保证其安全、有效的医疗器械。
The evaluation of the risk levels of medical devices shall take consideration of the expected objectives, structural features, use methods and other factors of medical devices. 评价医疗器械风险程度,应当考虑医疗器械的预期目的、结构特征、使用方法等因素。
The medical products administration of the State Council shall be responsible for developing the classification rules for and the classified catalogues of medical devices, and, according to the information on the production, distribution and use of medical devices, analyzing and evaluating in a timely manner the risk changes of medical devices and adjusting the classification rules and classified catalogues; and shall develop and adjust the classification rules and classified catalogues, fully listen to the opinions of medical device registrants, recordation entities, production and distribution enterprises, use entities and industry organizations, and conduct the classified practices by reference to those for international medical devices. The classification rules for and the classified catalogues of medical devices shall be announced to the general public. 国务院药品监督管理部门负责制定医疗器械的分类规则和分类目录,并根据医疗器械生产、经营、使用情况,及时对医疗器械的风险变化进行分析、评价,对分类规则和分类目录进行调整。制定、调整分类规则和分类目录,应当充分听取医疗器械注册人、备案人、生产经营企业以及使用单位、行业组织的意见,并参考国际医疗器械分类实践。医疗器械分类规则和分类目录应当向社会公布。
Article 7 Medical device products shall satisfy the national compulsory standards for medical devices, and, if no such standard is available, meet the compulsory industry standards for medical devices.   第七条 医疗器械产品应当符合医疗器械强制性国家标准;尚无强制性国家标准的,应当符合医疗器械强制性行业标准。
Article 8 The state shall develop the plans and policies on the medical device industry, include medical device innovation in the scope of development priorities, give priority to the evaluation and approval of innovative medical devices, support the clinical promotion and use of innovative medical devices, and promote the high-quality development of the medical device industry. The medical products administration of the State Council shall cooperate with the relevant departments of the State Council to implement the national plans and guiding policies on the medical device industry.   第八条 国家制定医疗器械产业规划和政策,将医疗器械创新纳入发展重点,对创新医疗器械予以优先审评审批,支持创新医疗器械临床推广和使用,推动医疗器械产业高质量发展。国务院药品监督管理部门应当配合国务院有关部门,贯彻实施国家医疗器械产业规划和引导政策。
Article 9 The state shall improve the medical device innovation system, support the basic research and application research of medical devices, promote the promotion and application of new medical device technologies, and provide support in initiation of scientific and technological projects, financing, credit, procurement through bidding, medical insurance and other aspects. Enterprises shall be supported in establishing or jointly forming research and development institutions, and be encouraged to cooperate with institutions of higher education, scientific research institutes, and medical institutions, among others, in conducting research and making innovations on medical devices, strengthen the intellectual property protection for medical devices, and improve independent innovation capabilities in terms of medical devices.   第九条 国家完善医疗器械创新体系,支持医疗器械的基础研究和应用研究,促进医疗器械新技术的推广和应用,在科技立项、融资、信贷、招标采购、医疗保险等方面予以支持。支持企业设立或者联合组建研制机构,鼓励企业与高等学校、科研院所、医疗机构等合作开展医疗器械的研究与创新,加强医疗器械知识产权保护,提高医疗器械自主创新能力。
Article 10 The state shall strengthen the information technology construction for the supervision and administration of medical devices, enhance the level of online government services, and facilitate the handling of administrative licensing and recordation of medical devices.   第十条 国家加强医疗器械监督管理信息化建设,提高在线政务服务水平,为医疗器械行政许可、备案等提供便利。
Article 11 Medical device industry organizations shall strengthen industry self-regulation, promote the construction of the credit system, urge and supervise enterprises’ implementation of production and distribution activities according to the law, and direct enterprises to act in good faith.   第十一条 医疗器械行业组织应当加强行业自律,推进诚信体系建设,督促企业依法开展生产经营活动,引导企业诚实守信。
Article 12 The entities and individuals that have made outstanding contributions in research and innovation of medical devices shall be commended and rewarded in accordance with the relevant provisions issued by the state.   第十二条 对在医疗器械的研究与创新方面做出突出贡献的单位和个人,按照国家有关规定给予表彰奖励。
Chapter II Registration and Recordation of Medical Device Products 第二章 医疗器械产品注册与备案
Article 13 The medical devices of Class I shall be subject to product recordation administration, and the medical devices of Class II and Class III shall be subject to product registration administration.   第十三条 第一类医疗器械实行产品备案管理,第二类、第三类医疗器械实行产品注册管理。
Medical device registrants and recordation entities shall strengthen the whole life-cycle quality management of medical devices, and assume responsibilities according to the law for the safety and effectiveness of medical devices in the process of research and development, production, distribution and use thereof. 医疗器械注册人、备案人应当加强医疗器械全生命周期质量管理,对研制、生产、经营、使用全过程中医疗器械的安全性、有效性依法承担责任。
Article 14 The following materials shall be submitted for the recordation of the medical device products of Class I and the application for registration of the medical device products of Class II and Class III:   第十四条 第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(1) Product risk analysis materials. (一)产品风险分析资料;
(2) Product technical requirements. (二)产品技术要求;
(3) Product inspection reports. (三)产品检验报告;
(4) Clinical evaluation materials. (四)临床评价资料;
(5) Sample manuscripts of product instructions and labels. (五)产品说明书以及标签样稿;
(6) Quality management system documents with respect to product research, development and production. (六)与产品研制、生产有关的质量管理体系文件;
(7) Other materials required to prove the safety and effectiveness of the products. (七)证明产品安全、有效所需的其他资料。
Product inspection reports shall meet the requirements of the medical products administration of the State Council, which may be the self-inspection reports of medical device registration applicants and recordation entities or the inspection reports issued by the qualified medical device inspection institutions commissioned by them. 产品检验报告应当符合国务院药品监督管理部门的要求,可以是医疗器械注册申请人、备案人的自检报告,也可以是委托有资质的医疗器械检验机构出具的检验报告。
Those falling under the circumstances that clinical evaluation may be exempted as prescribed in Article 24 of this Regulation may be exempt from submitting clinical evaluation materials. 符合本条例第二十四条规定的免于进行临床评价情形的,可以免于提交临床评价资料。
Medical device registration applicants and recordation entities shall ensure that the materials submitted are legal, authentic, accurate, complete and traceable. 医疗器械注册申请人、备案人应当确保提交的资料合法、真实、准确、完整和可追溯。
Article 15 For the recordation of the medical device products of Class I, recordation entities shall submit the recordation materials to the medical products administrations of the local people’s government at the districted city level.   第十五条 第一类医疗器械产品备案,由备案人向所在地设区的市级人民政府负责药品监督管理的部门提交备案资料。
Where any overseas recordation entity exports the medical devices of Class I to the territory of China, the enterprise legal person within the territory of China designated by it shall submit to the medical products administration of the State Council the recordation materials and the documents certifying the approval of the marketing of such medical devices by the competent department in the country (region) where the recordation entity is located. For innovative medical devices that have not been marketed abroad, it is allowed not to submit the documents certifying the approval of the marketing of such medical devices by the competent department in the country (region) where the recordation entity is located. 向我国境内出口第一类医疗器械的境外备案人,由其指定的我国境内企业法人向国务院药品监督管理部门提交备案资料和备案人所在国(地区)主管部门准许该医疗器械上市销售的证明文件。未在境外上市的创新医疗器械,可以不提交备案人所在国(地区)主管部门准许该医疗器械上市销售的证明文件。
Recordation formalities are completed once a recordation entity submits the recordation materials that meet the provisions of this Regulation to the medical products administration. The medical products administration shall, within five working days from the date of receipt of the recordation materials, announce relevant recordation information to the general public through the online government service platform of the medical products administration of the State Council. 备案人向负责药品监督管理的部门提交符合本条例规定的备案资料后即完成备案。负责药品监督管理的部门应当自收到备案资料之日起5个工作日内,通过国务院药品监督管理部门在线政务服务平台向社会公布备案有关信息。
In case of any change of the matters as specified in the recordation materials, the recordation shall be modified at the original recordation department. 备案资料载明的事项发生变化的,应当向原备案部门变更备案。
Article 16 To apply for the registration of the medical device products of Class II, registration applicants shall submit registration application materials to the medical products administrations of the people’s governments of the provinces, autonomous regions or municipalities directly under the Central Government where such applicants are located. To apply for the registration of the medical device products of Class III, registration applicants shall submit the registration application materials to the medical products administration of the State Council.   第十六条 申请第二类医疗器械产品注册,注册申请人应当向所在地省、自治区、直辖市人民政府药品监督管理部门提交注册申请资料。申请第三类医疗器械产品注册,注册申请人应当向国务院药品监督管理部门提交注册申请资料。
Where any overseas registration applicant exports the medical devices of Class II or III to the territory of China, the enterprise legal person within the territory of China designated by it shall submit to the medical products administration of the State Council the registration application materials and the documents certifying the approval of the marketing of such medical devices by the competent department in the country (region) where the registration applicant is located. For innovative medical devices that have not been marketed abroad, it is allowed not to submit the documents certifying the approval of the marketing of such medical devices by the competent department in the country (region) where the registration applicant is located. 向我国境内出口第二类、第三类医疗器械的境外注册申请人,由其指定的我国境内企业法人向国务院药品监督管理部门提交注册申请资料和注册申请人所在国(地区)主管部门准许该医疗器械上市销售的证明文件。未在境外上市的创新医疗器械,可以不提交注册申请人所在国(地区)主管部门准许该医疗器械上市销售的证明文件。
The medical products administration of the State Council shall provide for the procedures and requirements for the examination of medical device registration, and strengthen the supervision and guidance of the registration examination by the medical products administrations of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government. 国务院药品监督管理部门应当对医疗器械注册审查程序和要求作出规定,并加强对省、自治区、直辖市人民政府药品监督管理部门注册审查工作的监督指导。
Article 17 The medical products administrations that accept registration applications shall examine the safety and effectiveness of medical devices as well as registration applicants’ capabilities of ensuring the safe and effective quality management of medical devices.   第十七条 受理注册申请的药品监督管理部门应当对医疗器械的安全性、有效性以及注册申请人保证医疗器械安全、有效的质量管理能力等进行审查。
The medical product administration that accepts a registration application shall, within three working days from the date of acceptance of the registration application, transfer the registration application materials to a technical review institution. The technical review institution shall, after completing the technical review, submit the review opinions to the medical products administration that accepts the registration application as the basis for approval. 受理注册申请的药品监督管理部门应当自受理注册申请之日起3个工作日内将注册申请资料转交技术审评机构。技术审评机构应当在完成技术审评后,将审评意见提交受理注册申请的药品监督管理部门作为审批的依据。
Where the medical products administration that accepts a registration application deems that it is necessary to verify the quality management system when organizing a technical review of any medical devices, it shall organize the verification of the quality management system. 受理注册申请的药品监督管理部门在组织对医疗器械的技术审评时认为有必要对质量管理体系进行核查的,应当组织开展质量管理体系核查。
Article 18 The medical products administration that accepts a registration application shall make a decision within 20 working days from the date when the review opinions are received. The medical devices which meet the requirements shall be granted registration, and the medical device registration certificate shall be issued thereto. For those failing to meet the requirements, the registration shall be denied and the reasons therefor shall be given in writing.   第十八条 受理注册申请的药品监督管理部门应当自收到审评意见之日起20个工作日内作出决定。对符合条件的,准予注册并发给医疗器械注册证;对不符合条件的,不予注册并书面说明理由。
The medical products administration that accepts a registration application shall, within five working days from the date when medical devices are granted registration, release relevant registration information to the public through the online government service platform of the medical products administration of the State Council. 受理注册申请的药品监督管理部门应当自医疗器械准予注册之日起5个工作日内,通过国务院药品监督管理部门在线政务服务平台向社会公布注册有关信息。
Article 19 With respect to the medical devices used for treating rare diseases and serious life-threatening diseases for which there has been no effective treatment method or the medical devices urgently needed to respond to public health emergencies, the medical products administrations that accept registration applications may make conditional approval decisions, and specify relevant matters in the medical device registration certificates.   第十九条 对用于治疗罕见疾病、严重危及生命且尚无有效治疗手段的疾病和应对公共卫生事件等急需的医疗器械,受理注册申请的药品监督管理部门可以作出附条件批准决定,并在医疗器械注册证中载明相关事项。
In the case of any particularly serious public health emergency or any other emergency that poses a serious threat to public health, the health department of the State Council shall offer a proposal on the urgent use of medical devices as required for the prevention and control of the event, and medical devices may be put into urgent use within a certain scope and during specified period with the approval after discussions organized by the medical products administration of the State Council. 出现特别重大突发公共卫生事件或者其他严重威胁公众健康的紧急事件,国务院卫生主管部门根据预防、控制事件的需要提出紧急使用医疗器械的建议,经国务院药品监督管理部门组织论证同意后可以在一定范围和期限内紧急使用。
Article 20 Medical device registrants and recordation entities shall perform the following obligations:   第二十条 医疗器械注册人、备案人应当履行下列义务:
(1) Establishing the quality management systems commensurate with products and maintaining the effective operation thereof. (一)建立与产品相适应的质量管理体系并保持有效运行;
(2) Developing the plans for research after the marketing of medical devices and risk management and control and ensuring the effective implementation thereof. (二)制定上市后研究和风险管控计划并保证有效实施;
(3) Conducting adverse event monitoring and re-evaluation according to the law. (三)依法开展不良事件监测和再评价;
(4) Establishing and implementing the product traceability and recall rules. (四)建立并执行产品追溯和召回制度;
(5) Other obligations as prescribed by the medical products administration of the State Council. (五)国务院药品监督管理部门规定的其他义务。
The domestic enterprise legal persons designated by overseas medical device registrants and recordation entities shall support registrants and recordation entities in fulfilling the obligations as prescribed in the preceding paragraph. 境外医疗器械注册人、备案人指定的我国境内企业法人应当协助注册人、备案人履行前款规定的义务。
Article 21 In case of any substantial changes of the designs, raw materials, production technologies, scopes of application or application methods, among others, of the registered medical device products of Class II or Class III, which may affect the safety and effectiveness of such medical devices, registrants shall apply to the original registration departments for undergoing the formalities for registration modification. In case of any other change thereof, recordation formalities shall be undergone or a report shall be made in accordance with the provisions issued by the medical products administration of the State Council.   第二十一条 已注册的第二类、第三类医疗器械产品,其设计、原材料、生产工艺、适用范围、使用方法等发生实质性变化,有可能影响该医疗器械安全、有效的,注册人应当向原注册部门申请办理变更注册手续;发生其他变化的,应当按照国务院药品监督管理部门的规定备案或者报告。
Article 22 A medical device registration certificate shall be valid for five years. If the registration of a medical device registration certificate needs to be renewed upon the expiration of its validity period, an application for registration renewal shall be filed with the original registration department six months before the validity period expires.   第二十二条 医疗器械注册证有效期为5年。有效期届满需要延续注册的,应当在有效期届满6个月前向原注册部门提出延续注册的申请。
Except for the circumstances as prescribed in Paragraph 3 of this Article, the medical products administration that receives the registration renewal application shall make a decision on whether to approve the renewal thereof prior to the expiration of the medical device registration certificate. Any failure to make such a decision during a specified period shall be deemed as the approval of the renewal. 除有本条第三款规定情形外,接到延续注册申请的药品监督管理部门应当在医疗器械注册证有效期届满前作出准予延续的决定。逾期未作决定的,视为准予延续。
Under any of the following circumstances, registration shall not be renewed: 有下列情形之一的,不予延续注册:
(1) The registrant fails to file a registration renewal application during a specified period. (一)未在规定期限内提出延续注册申请;
(2) The compulsory standards for medical devices have been revised, and the medical devices subject to the application for registration renewal fail to meet the new requirements. (二)医疗器械强制性标准已经修订,申请延续注册的医疗器械不能达到新要求;
(3) The matters as specified in the medical device registration certificates for the medical devices subject to conditional approval fail to be completed during a specified period. (三)附条件批准的医疗器械,未在规定期限内完成医疗器械注册证载明事项。
Article 23 For the newly researched and developed medical devices which have not been listed in the classified categories, applicants may directly apply for product registration in accordance with the provisions of this Regulation on the registration of the medical device products of Class III, or, according to the classification rules, determine product categories, and apply for product registration or recordation in accordance with the provisions of this Regulation after applying for category confirmation to the medical products administration of the State Council.   第二十三条 对新研制的尚未列入分类目录的医疗器械,申请人可以依照本条例有关第三类医疗器械产品注册的规定直接申请产品注册,也可以依据分类规则判断产品类别并向国务院药品监督管理部门申请类别确认后依照本条例的规定申请产品注册或者进行产品备案。
For any direct applications for the registration of the medical device products of Class III, the medical products administration of the State Council shall determine the categories according to risk levels, and incorporate the medical devices granted registration into the classified catalogues in a timely manner. Where any application for category confirmation is filed, the medical products administration of the State Council shall, within 20 working days from the date of acceptance of the application, determine the category of relevant medical devices and inform the applicant of the determination result. 直接申请第三类医疗器械产品注册的,国务院药品监督管理部门应当按照风险程度确定类别,对准予注册的医疗器械及时纳入分类目录。申请类别确认的,国务院药品监督管理部门应当自受理申请之日起20个工作日内对该医疗器械的类别进行判定并告知申请人。
Article 24 Clinical evaluation is required for the registration and recordation of medical device products. However, medical devices may be exempt from clinical evaluation under any of the following circumstances:   第二十四条 医疗器械产品注册、备案,应当进行临床评价;但是符合下列情形之一,可以免于进行临床评价:
(1) The same categories of the marketed medical devices with clear and definite working mechanisms, finalized designs and mature production technologies have been put into clinical application for years, with no record of any severely adverse event and with their general purposes 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 effectiveness of such medical devices can be proved through non-clinical evaluation. (二)其他通过非临床评价能够证明该医疗器械安全、有效的。
The medical products administration of the State Council shall develop the guidelines for clinical evaluation of medical devices. 国务院药品监督管理部门应当制定医疗器械临床评价指南。
Article 25 In the clinical evaluation of medical devices, the safety and effectiveness of medical devices may be proved by conducting clinical trials or by conducting analysis of clinical literatures and materials on different types of medical devices and clinical data based on product features, clinical risks, existing clinical data, and other information.   第二十五条 进行医疗器械临床评价,可以根据产品特征、临床风险、已有临床数据等情形,通过开展临床试验,或者通过对同品种医疗器械临床文献资料、临床数据进行分析评价,证明医疗器械安全、有效。
In accordance with the provisions issued by the medical products administration of the State Council, if existing clinical literatures and materials or clinical data are insufficient to confirm the safety and effectiveness of medical devices during the clinical evaluation of medical devices, clinical trials shall be conducted. 按照国务院药品监督管理部门的规定,进行医疗器械临床评价时,已有临床文献资料、临床数据不足以确认产品安全、有效的医疗器械,应当开展临床试验。
Article 26 The clinical trials of medical devices shall be conducted in the clinical trial institutions that meet the corresponding conditions in accordance with the requirements of the quality management norms for the clinical trials of medical devices, and be filed with the medical products administrations of the people’s governments of the provinces, autonomous regions or municipalities directly under the Central Government where sponsors of clinical trials are located. The medical products administrations that accept the clinical trial recordation shall notify the recordation information to the medical products administrations and health departments at the same level at the places where clinical trial institutions are located.   第二十六条 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,在具备相应条件的临床试验机构进行,并向临床试验申办者所在地省、自治区、直辖市人民政府药品监督管理部门备案。接受临床试验备案的药品监督管理部门应当将备案情况通报临床试验机构所在地同级药品监督管理部门和卫生主管部门。
Medical device clinical trial institutions shall be subject to recordation administration. The conditions that medical device clinical trial institutions shall satisfy and recordation administration measures and clinical trial quality management norms shall be developed and published by the medical products administration of the State Council in conjunction with the health department of the State Council. 医疗器械临床试验机构实行备案管理。医疗器械临床试验机构应当具备的条件以及备案管理办法和临床试验质量管理规范,由国务院药品监督管理部门会同国务院卫生主管部门制定并公布。
The state shall support medical institutions in conducting clinical trials, include the evaluation of conditions and capacities of clinical trials in the rating of medical institutions, and encourage medical institutions to conduct clinical trials of innovative medical devices. 国家支持医疗机构开展临床试验,将临床试验条件和能力评价纳入医疗机构等级评审,鼓励医疗机构开展创新医疗器械临床试验。
Article 27 The medical devices of Class III which may pose relatively high risks to human bodies shall be subject to approval by the medical products administration of the State Council. The medical products administration of the State Council shall, when approving a clinical trial, conduct a comprehensive analysis on the devices, professionals and other conditions of the institution that is to undertake the medical device clinical trial, the risk level of such medical devices, the implementation plan for the clinical trial, and the clinical benefit and risk comparison and analysis report, among others, and make a decision within 60 working days of acceptance of the application and notify the sponsor of the clinical trial. Where it fails to notify the sponsor during the specified period, it shall be deemed to have approved the clinical trial. Where any clinical trial is approved, a notification shall be given to the medical products administration and the health department of the people’s government of the province, autonomous region or municipality directly under the Central Government at the place where the clinical trial institution is located.   第二十七条 第三类医疗器械临床试验对人体具有较高风险的,应当经国务院药品监督管理部门批准。国务院药品监督管理部门审批临床试验,应当对拟承担医疗器械临床试验的机构的设备、专业人员等条件,该医疗器械的风险程度,临床试验实施方案,临床受益与风险对比分析报告等进行综合分析,并自受理申请之日起60个工作日内作出决定并通知临床试验申办者。逾期未通知的,视为同意。准予开展临床试验的,应当通报临床试验机构所在地省、自治区、直辖市人民政府药品监督管理部门和卫生主管部门。
The catalogue of the medical devices of Class III which may pose relatively high risks to human bodies shall be developed, adjusted and published by the medical products administration of the State Council. 临床试验对人体具有较高风险的第三类医疗器械目录由国务院药品监督管理部门制定、调整并公布。
Article 28 To conduct clinical trials of medical devices, ethical review shall be conducted as required, the subjects shall be notified of the trial purposes, uses, possible risks and other details, and their written informed consent shall be obtained. If the subject is a person without capacity for civil conduct or with limited capacity for civil conduct, the written informed consent of his or her guardian shall be obtained.   第二十八条 开展医疗器械临床试验,应当按照规定进行伦理审查,向受试者告知试验目的、用途和可能产生的风险等详细情况,获得受试者的书面知情同意;受试者为无民事行为能力人或者限制民事行为能力人的,应当依法获得其监护人的书面知情同意。
When clinical trials are conducted, no fees related to clinical trials may be collected from subjects in any form. 开展临床试验,不得以任何形式向受试者收取与临床试验有关的费用。
Article 29 The medical devices that are undergoing clinical trials and used for the treatment of serious life-threatening diseases for which there has been no effective treatment method, and may possibly benefit patients as indicated by medical observation may, upon ethical review and informed consent, be used free of charge to treat patients suffering from the same diseases in the institutions that conduct the clinical trials of medical devices, and the safety data on such medical devices may be used for medical device registration applications.   第二十九条 对正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段的疾病的医疗器械,经医学观察可能使患者获益,经伦理审查、知情同意后,可以在开展医疗器械临床试验的机构内免费用于其他病情相同的患者,其安全性数据可以用于医疗器械注册申请。
Chapter III Production of Medical Devices 第三章 医疗器械生产
Article 30 An enterprise engaging in the production of medical devices shall meet the following conditions:   第三十条 从事医疗器械生产活动,应当具备下列条件:
(1) Having the production site, environmental conditions, production equipment and professional technicians commensurate with the medical devices produced by it. (一)有与生产的医疗器械相适应的生产场地、环境条件、生产设备以及专业技术人员;
(2) Having the institution or full-time inspection personnel and the inspection equipment for the quality inspection of the medical devices produced by it. (二)有能对生产的医疗器械进行质量检验的机构或者专职检验人员以及检验设备;
(3) Having the management system able to ensure the quality of medical devices. (三)有保证医疗器械质量的管理制度;
(4) Having the after-sales service abilities commensurate with the medical devices produced by it. (四)有与生产的医疗器械相适应的售后服务能力;
(5) Meeting the requirements as prescribed in the production research and development and production process documents. (五)符合产品研制、生产工艺文件规定的要求。
Article 31 The enterprises engaging in the production of the medical devices of Class I shall undergo the recordation formalities with the medical products administrations of the local people’s governments at the districted city level, and recordation formalities are completed once the enterprises submit the relevant materials that meet the conditions as prescribed in Article 30 of this Regulation.   第三十一条 从事第一类医疗器械生产的,应当向所在地设区的市级人民政府负责药品监督管理的部门备案,在提交符合本条例第三十条规定条件的有关资料后即完成备案。
The medical device recordation entities which produce the medical devices of Class I by themselves may, when undergoing the product recordation formalities in accordance with the provisions of Article 15 of this Regulation, submit the relevant materials that meet the conditions specified in Article 30 of this Regulation, then that is completing the production recordation formalities. 医疗器械备案人自行生产第一类医疗器械的,可以在依照本条例第十五条规定进行产品备案时一并提交符合本条例第三十条规定条件的有关资料,即完成生产备案。
Article 32 The enterprises engaging in the production of the medical devices of Class II and Class III shall apply for production licenses to the medical products administrations of the local people’s governments of the provinces, autonomous regions or municipalities directly under the Central Government, and submit the materials certifying their compliance with the conditions as prescribed in Article 30 of this Regulation and the registration certificates of the medical devices produced by them.   第三十二条 从事第二类、第三类医疗器械生产的,应当向所在地省、自治区、直辖市人民政府药品监督管理部门申请生产许可并提交其符合本条例第三十条规定条件的有关资料以及所生产医疗器械的注册证。
A medical products administration that accepts a production license application shall review the application materials, conduct verification in accordance with the requirements of the quality management norms for the production of medical devices developed by the medical products administration of the State Council, and make a decision within 20 working days from the date of acceptance of the application. Where an application meets the specified conditions, approval shall be granted and a medical device production license shall be issued thereto; otherwise, no approval shall be granted and the reasons therefor shall be given in writing. 受理生产许可申请的药品监督管理部门应当对申请资料进行审核,按照国务院药品监督管理部门制定的医疗器械生产质量管理规范的要求进行核查,并自受理申请之日起20个工作日内作出决定。对符合规定条件的,准予许可并发给医疗器械生产许可证;对不符合规定条件的,不予许可并书面说明理由。
A medical device production license shall be valid for five years. If a medical device production license needs to be renewed upon the expiration of its validity period, the renewal formalities shall be handled in accordance with the relevant legal provisions on administrative licensing. 医疗器械生产许可证有效期为5年。有效期届满需要延续的,依照有关行政许可的法律规定办理延续手续。
Article 33 The quality management norms for the production of medical devices shall explicitly specify the design and development of medical devices, production equipment conditions, raw material purchase, production process control, product release, institutional setup and staffing of the enterprises and other matters which may affect the safety and effectiveness of medical devices.   第三十三条 医疗器械生产质量管理规范应当对医疗器械的设计开发、生产设备条件、原材料采购、生产过程控制、产品放行、企业的机构设置和人员配备等影响医疗器械安全、有效的事项作出明确规定。
Article 34 Medical device registrants and recordation entities may produce medical devices by themselves, or commission the enterprises that comply with the provisions of this Regulation and meet corresponding conditions to produce medical devices.   第三十四条 医疗器械注册人、备案人可以自行生产医疗器械,也可以委托符合本条例规定、具备相应条件的企业生产医疗器械。
In case of commissioned production of medical devices, medical device registrants and recordation entities shall be responsible for the quality of the medical devices the production of which is commissioned, and strengthen the administration of the production by the commissioned production enterprises to ensure that they are produced according to legal requirements. Medical device registrants and recordation entities shall conclude commission agreements with the commissioned production enterprises to specify the rights, obligations and responsibilities of both parties. The commissioned production enterprises shall organize production in accordance with laws, regulations, quality management norms for the production of medical devices, compulsory national standards, technical requirements for products and commission agreements, be responsible for production, and be subject to supervision by the commissioning parties. 委托生产医疗器械的,医疗器械注册人、备案人应当对所委托生产的医疗器械质量负责,并加强对受托生产企业生产行为的管理,保证其按照法定要求进行生产。医疗器械注册人、备案人应当与受托生产企业签订委托协议,明确双方权利、义务和责任。受托生产企业应当依照法律法规、医疗器械生产质量管理规范、强制性标准、产品技术要求和委托协议组织生产,对生产行为负责,并接受委托方的监督。
The implantable medical devices with high risks may not be produced on a commission basis. The specific catalogues shall be developed, adjusted and published by the medical products administration of the State Council. 具有高风险的植入性医疗器械不得委托生产,具体目录由国务院药品监督管理部门制定、调整并公布。
Article 35 Medical device registrants and recordation entities and commissioned production enterprises shall, in accordance with the quality management norms for the production of medical devices, establish and improve the quality management systems commensurate with the medical devices produced by them and ensure the effective operation of such medical devices; and shall organize production in strict accordance with the technical requirements for the products subject to registration or recordation to ensure the medical devices leaving factory meet the compulsory standards and the technical requirements for the products subject to registration or recordation.   第三十五条 医疗器械注册人、备案人、受托生产企业应当按照医疗器械生产质量管理规范,建立健全与所生产医疗器械相适应的质量管理体系并保证其有效运行;严格按照经注册或者备案的产品技术要求组织生产,保证出厂的医疗器械符合强制性标准以及经注册或者备案的产品技术要求。
Medical device registrants and recordation entities and commissioned production enterprises shall conduct self-inspection on the operation of the quality management system on a regular basis, and submit self-inspection reports according to the provisions issued by the medical products administration of the State Council. 医疗器械注册人、备案人、受托生产企业应当定期对质量管理体系的运行情况进行自查,并按照国务院药品监督管理部门的规定提交自查报告。
Article 36 Where the production conditions of medical devices change and no longer meet the requirements of the medical device quality management system, medical device registrants and recordation entities and commissioned production enterprises shall immediately take rectification measures; and, if the safety and effectiveness of such medical devices may be affected, immediately stop the production thereof, and report to the original production licensing or production recordation departments.   第三十六条 医疗器械的生产条件发生变化,不再符合医疗器械质量管理体系要求的,医疗器械注册人、备案人、受托生产企业应当立即采取整改措施;可能影响医疗器械安全、有效的,应当立即停止生产活动,并向原生产许可或者生产备案部门报告。
Article 37 Medical devices shall have generic names. Generic names shall comply with the naming rules for medical devices developed by the medical products administration of the State Council.   第三十七条 医疗器械应当使用通用名称。通用名称应当符合国务院药品监督管理部门制定的医疗器械命名规则。
Article 38 The state shall, according to the categories of medical device products, implement the unique identification system for medical devices step by step and realize the traceability of medical devices. The specific measures shall be developed by the medical products administration of the State Council in conjunction with relevant departments of the State Council.   第三十八条 国家根据医疗器械产品类别,分步实施医疗器械唯一标识制度,实现医疗器械可追溯,具体办法由国务院药品监督管理部门会同国务院有关部门制定。
Article 39 Medical devices shall be accompanied with instructions and labels. The contents of instructions and labels shall be kept consistent with the relevant contents subject to registration or recordation, and the authenticity and accuracy thereof shall be ensured.   第三十九条 医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备案的相关内容一致,确保真实、准确。
......