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Order of the State Council of the People's Republic of China | | 中华人民共和国国务院令 |
| (No. 650) | | （第650号） |
| The Regulation on the Supervision and Administration of Medical Devices, as revised and adopted at the 39th executive meeting of the State Council on February 12, 2014, is hereby promulgated and shall come into force on June 1, 2014. | | 《医疗器械监督管理条例》已经2014年2月12日国务院第39次常务会议修订通过，现将修订后的《医疗器械监督管理条例》公布，自2014年6月1日起施行。 |
| Premier: Li Keqiang | | 总理 李克强 |
| March 7, 2014 | | 2014年3月7日 |
| Regulation on the Supervision and Administration of Medical Devices | | 医疗器械监督管理条例 |
| (Promulgated by Order No.276 of the State Council of the People's Republic of China on January 4, 2000, and revised and adopted at the 39th executive meeting of the State Council on February 12, 2014) | | （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） |
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| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 This Regulation is formulated for the purposes of ensuring the safety and effectiveness of medical devices and guaranteeing human health and life safety. | | 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，制定本条例。 |
| Article 2 Whoever engages in the research and development, production, operation, use as well as supervision and administration of medical devices 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，应当遵守本条例。 |
| Article 3 The food and drug supervision and administration department of the State Council shall be responsible for the supervision and administration of the medical devices nationwide. The relevant departments of the State Council shall be responsible for the supervision and administration with respect to medical devices within their respective functions. | | 第三条 国务院食品药品监督管理部门负责全国医疗器械监督管理工作。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。 |
| The food and drug supervision and administration departments 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 with respect to medical devices within their respective functions. | | 县级以上地方人民政府食品药品监督管理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。 |
| The food and drug supervision and administration department of the State Council shall cooperate with the relevant departments of the State Council to implement the national plans and policies on the medical device industry. | | 国务院食品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政策。 |
| Article 4 The state shall conduct the classification administration of medical devices according to their risk levels. | | 第四条 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 food and drug supervision and administration department of the State Council shall be responsible for formulating the classification rules for and the classified catalogues of medical devices, and, according to the information on the production, operation and use of medical devices, timely analyzing and evaluating the risk changes of medical devices, and adjusting the classified catalogues; and shall formulate and adjust the classified catalogues, fully listen to the opinions of the production and operation enterprises, use entities and industry organizations of medical devices, and, conduct the classified practices by reference to those for international medical devices. The classified catalogues of medical devices shall be announced to the general public. | | 国务院食品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，对分类目录进行调整。制定、调整分类目录，应当充分听取医疗器械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。医疗器械分类目录应当向社会公布。 |
| Article 5 The research and development of medical devices shall follow the principles of safety, effectiveness and economy. The state shall encourage the research and innovation of medical devices, and maximize the role of the market mechanism to promote the popularization and application of new technologies in medical devices, and drive the development of the medical device industry. | | 第五条 医疗器械的研制应当遵循安全、有效和节约的原则。国家鼓励医疗器械的研究与创新，发挥市场机制的作用，促进医疗器械新技术的推广和应用，推动医疗器械产业的发展。 |
| Article 6 The 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. | | 第六条 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。 |
| The catalogue of single-use medical devices shall be formulated, adjusted and published by the food and drug supervision and administration department of the State Council jointly with the administrative department of health and family planning of the State Council. The medical devices whose safety and effectiveness can be ensured when being reused shall not be listed in the catalogue of single-use medical devices. The medical devices whose safety and effectiveness can be ensured when being reused due to the improvements in designs, production technologies, disinfection and sterilization technologies, etc. shall be removed from the catalogue of single-use medical devices. | | 一次性使用的医疗器械目录由国务院食品药品监督管理部门会同国务院卫生计生主管部门制定、调整并公布。重复使用可以保证安全、有效的医疗器械，不列入一次性使用的医疗器械目录。对因设计、生产工艺、消毒灭菌技术等改进后重复使用可以保证安全、有效的医疗器械，应当调整出一次性使用的医疗器械目录。 |
| Article 7 The medical device industry organizations shall strengthen the industry self-regulation, promote the construction of credit system, urge enterprises to conduct production and operation activities in accordance with the law, and guide enterprises to act in good faith. | | 第七条 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。 |
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| Chapter II Registration and Recordation of Medical Device Products | | 第二章 医疗器械产品注册与备案 |
| Article 8 The medical devices of Class I shall be subject to the product recordation administration, and the medical devices of Class II and Class III shall be subject to the product registration administration. | | 第八条 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。 |
| Article 9 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: | | 第九条 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。 |
| Medical device registration applicants and the parties undergoing recordation of medical devices shall be responsible for the authenticity of the materials submitted by them. | | 医疗器械注册申请人、备案人应当对所提交资料的真实性负责。 |
| Article 10 For the recordation of the medical device products of Class I, the parties undergoing recordation of medical devices shall submit the recordation materials to the food and drug supervision and administration departments of the local people's government at the districted city level. The product inspection reports thereof may be the self-inspection reports of the parties undergoing recordation of medical devices, and the clinical evaluation materials thereof exclude clinical trial reports, and may be the materials capable of proving the safety and effectiveness of the medical devices through literatures or the data obtained from the clinical application of similar products. | | 第十条 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食品药品监督管理部门提交备案资料。其中，产品检验报告可以是备案人的自检报告；临床评价资料不包括临床试验报告，可以是通过文献、同类产品临床使用获得的数据证明该医疗器械安全、有效的资料。 |
| Where any overseas production enterprises export the medical devices of Class I to the territory of China, the representative offices established by them within the territory of China or the incorporated enterprises within the territory of China designed by them as agents shall submit to the food and drug supervision and administration department of the State Council the recordation materials and the documents certifying the approval of the marketing of such medical devices by the competent departments in the countries (regions) where the parties undergoing recordation of medical devices are located. | | 向我国境内出口第一类医疗器械的境外生产企业，由其在我国境内设立的代表机构或者指定我国境内的企业法人作为代理人，向国务院食品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。 |
| In case of any change of the matters as specified in the recordation materials, the recordation shall be modified at the original recordation departments. | | 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 11 To apply for the registration of the medical device products of Class II, registration applicants shall submit the registration application materials to the food and drug supervision and administration departments of the people's governments of the provinces, autonomous regions or municipality 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 food and drug supervision and administration department of the State Council. | | 第十一条 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、直辖市人民政府食品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食品药品监督管理部门提交注册申请资料。 |
| Where any overseas production enterprises export the medical devices of Class II and III to the territory of China, the representative offices established by them within the territory of China or the incorporated enterprises within the territory of China designed by them as agents shall submit to the food and drug supervision and administration department of the State Council the registration application materials and the documents certifying the approval of the marketing of such medical devices by the competent departments in the countries (regions) where the registration applicants are located | | 向我国境内出口第二类、第三类医疗器械的境外生产企业，应当由其在我国境内设立的代表机构或者指定我国境内的企业法人作为代理人，向国务院食品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。 |
| The product inspection reports amid the application materials for the registration of the medical device products of Class II and Class III shall be the inspection reports issued by the medical device inspection institutions. Clinical evaluation materials shall include clinical trial reports, but exclude the reports on the medical devices exempt from clinical trials in accordance with the provisions of Article 17 of this Regulation. | | 第二类、第三类医疗器械产品注册申请资料中的产品检验报告应当是医疗器械检验机构出具的检验报告；临床评价资料应当包括临床试验报告，但依照本条例第十七条的规定免于进行临床试验的医疗器械除外。 |
| Article 12 The food and drug supervision and administration departments accepting registration applications shall, within three working days from the dates of acceptance of applications, transfer the registration application materials to technical review institutions. Technical review institutions shall, after completing the technical review, submit the review opinions to food and drug supervision and administration departments. | | 第十二条 受理注册申请的食品药品监督管理部门应当自受理之日起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向食品药品监督管理部门提交审评意见。 |
| Article 13 The food and drug supervision and administration departments accepting registration applications shall make decisions within 20 working days from the dates when the review opinions are received. The medical devices which meet the safety and effectiveness requirements shall be approved to be registered, and the medical device registration certificates shall be issued thereto, and for those failing to meet the requirements, the registration applications thereof shall be denied and the reasons therefor shall be given in writing. | | 第十三条 受理注册申请的食品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。对符合安全、有效要求的，准予注册并发给医疗器械注册证；对不符合要求的，不予注册并书面说明理由。 |
| Where the food and drug supervision and administration department of the State Council deems that it is necessary to verify the quality management system when organizing a technical review on any imported medical devices, it shall authorize a technical institution for quality management system inspection to conduct the verification of the quality management system. | | 国务院食品药品监督管理部门在组织对进口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，应当组织质量管理体系检查技术机构开展质量管理体系核查。 |
| Article 14 In case of any substantial change of the designs, raw materials, production technologies, scopes of application and application methods, etc., of the registered medical device products of Class II or Class III, which may affect the safety and effectiveness of such medical devices, the registrants shall apply to the original registration departments for undergoing the formalities for registration modification. In case of any non-substantial change thereof, which do not affect the safety and effectiveness of such medical devices, the information on the change shall be reported to the original registration departments for recordation. | | 第十四条 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；发生非实质性变化，不影响该医疗器械安全、有效的，应当将变化情况向原注册部门备案。 |
| Article 15 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. | | 第十五条 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 food and drug supervision and administration department receiving 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. The failure to make such a decision within a prescribed time limit 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食品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。 |
| A registration shall not be renewed under any of the following circumstances: | | 有下列情形之一的，不予延续注册： |
| (1) The registrant fails to file a registration renewal application within a prescribed time limit. | | （一）注册人未在规定期限内提出延续注册申请的； |
| (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的； |
| (3) The matters as specified in the medical device registration certificate fails to be completed within a prescribed time limit with respect to the medical devices used for treating rare diseases or urgently needed to respond to public health emergencies. | | （三）对用于治疗罕见疾病以及应对突发公共卫生事件急需的医疗器械，未在规定期限内完成医疗器械注册证载明事项的。 |
| Article 16 For the newly researched and developed medical devices which have not been listed in the classified categories, applicants may directly apply for the product registration in accordance with the provisions of this Regulation on the registration of the medical device products of Class III, or may, according to the classification rules, determine the product categories, and apply for the product registration or recordation in accordance with the provisions of this Regulation after applying for the category confirmation to the food and drug supervision and administration department of the State Council. | | 第十六条 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食品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 food and drug supervision and administration department of the State Council shall determine the categories according to the risk levels, and timely incorporate the medical devices approved to be registered into the classified catalogues. Where any application categories have been confirmed, the food and drug supervision and administration department of the State Council shall, within 20 working days from the dates of acceptance of applications, determine the categories of such medical devices and inform the applicants of the determination results. | | 直接申请第三类医疗器械产品注册的，国务院食品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，国务院食品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 17 Clinical trials are not required for the recordation of the medical devices of Class I, but necessary for the application for the registration of the medical devices of Class II and Class III. However, medical devices may be exempt from clinical trials under any of the following circumstances: | | 第十七条 第一类医疗器械产品备案，不需要进行临床试验。申请第二类、第三类医疗器械产品注册，应当进行临床试验；但是，有下列情形之一的，可以免于进行临床试验： |
| (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 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）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 effectiveness of such medical devices can be proved through the analysis and evaluation of the data obtained from the clinical trials or clinical application of the same categories of medical devices. | | （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 the medical devices exempt from clinical trials shall be formulated, adjusted and published by the food and drug supervision and administration department of the State Council. | | 免于进行临床试验的医疗器械目录由国务院食品药品监督管理部门制定、调整并公布。 |
| Article 18 The clinical trials of medical devices shall be conducted in qualified clinical trial institutions in accordance with the requirements of the quality management norms for the clinical trials of medical devices, and be reported for recordation to the food and drug supervision and administration departments of the people's governments of the provinces, autonomous regions or municipalities directly under the Central Government where the clinical trial presenters are located. Food and drug supervision and administration departments accepting the clinical trial recordation shall notify the recordation information to food and drug supervision and administration departments and administrative departments of health and family planning at the same level in the places where the clinical trial institutions are located. | | 第十八条 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，在有资质的临床试验机构进行，并向临床试验提出者所在地省、自治区、直辖市人民政府食品药品监督管理部门备案。接受临床试验备案的食品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的同级食品药品监督管理部门和卫生计生主管部门。 |
| The qualification accreditation conditions of medical device clinical trial institutions and the clinical trial quality management norms shall be formulated and published by the food and drug supervision and administration department of the State Council jointly with the administrative department of health and family planning of the State Council. The medical device clinical trial institutions shall be determined and published by the food and drug supervision and administration department of the State Council jointly with the administrative department of health and family planning of the State Council. | | 医疗器械临床试验机构资质认定条件和临床试验质量管理规范，由国务院食品药品监督管理部门会同国务院卫生计生主管部门制定并公布；医疗器械临床试验机构由国务院食品药品监督管理部门会同国务院卫生计生主管部门认定并公布。 |
| Article 19 The medical devices of Class III which may pose relatively high risks to human bodies according to the clinical trials thereof shall be approved by the food and drug supervision and administration department of the State Council. The catalogue of the medical devices of Class III which may pose relatively high risks to human bodies according to the clinical trials thereof shall be formulated, adjusted and published by the food and drug supervision and administration department of the State Council. | | 第十九条 第三类医疗器械进行临床试验对人体具有较高风险的，应当经国务院食品药品监督管理部门批准。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食品药品监督管理部门制定、调整并公布。 |
| The food and drug supervision and administration department of the State Council shall, when approving clinical trials, conduct a comprehensive analysis on the devices, professionals and other conditions of the institutions planning to undertake the medical device clinical trials, the risk levels of such medical devices, the implementation plans for the clinical trials, and clinical benefit and risk comparison and analysis reports, etc.. Where any clinical trial is approved, a notification shall be given to the clinical trial presenter and the food and drug supervision and administration department and the administrative department of health and family planning of the people's government of the province, autonomous region or municipality directly under the Central Government where the clinical trial institution is located. | | 国务院食品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。准予开展临床试验的，应当通报临床试验提出者以及临床试验机构所在地省、自治区、直辖市人民政府食品药品监督管理部门和卫生计生主管部门。 |
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| Chapter III Production of Medical Devices | | 第三章 医疗器械生产 |
| Article 20 An enterprise engaging in the production of medical devices shall meet the following conditions: | | 第二十条 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 adaptive to 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 adaptive to 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）产品研制、生产工艺文件规定的要求。 |
| Article 21 The enterprises engaging in the production of the medical devices of Class I shall report themselves to the drug supervision and administration departments of the local people's governments at the districted city level for recordation and submit the materials certifying their compliance with the conditions as prescribed in Article 20 of this Regulation. | | 第二十一条 从事第一类医疗器械生产的，由生产企业向所在地设区的市级人民政府食品药品监督管理部门备案并提交其符合本条例第二十条规定条件的证明资料。 |
| Article 22 The enterprises engaging in the production of the medical devices of Class II and Class III shall apply for production licenses to the food and drug supervision and administration departments 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 20 of this Regulation and the registration certificates of the medical devices produced by them. | | 第二十二条 从事第二类、第三类医疗器械生产的，生产企业应当向所在地省、自治区、直辖市人民政府食品药品监督管理部门申请生产许可并提交其符合本条例第二十条规定条件的证明资料以及所生产医疗器械的注册证。 |
| The food and drug supervision and administration departments accepting production licenses shall review the application materials within 30 working days from the dates of acceptance of applications, and conduct verification in accordance with the requirements of the quality management norms for the production of medical devices. For those meeting the conditions as prescribed, permission shall be granted, and the medical device production licenses shall be issued thereto, and for those failing to meet the conditions, no permission shall be granted, and the reasons therefor shall be given in writing. | | 受理生产许可申请的食品药品监督管理部门应当自受理之日起30个工作日内对申请资料进行审核，按照国务院食品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。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 23 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, institutional setup and staffing of the enterprises and other matters which may affect the safety and effectiveness of medical devices. | | 第二十三条 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、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 24 The medical device production enterprises shall, in accordance with the requirements of the quality management norms for the production of medical devices production, establish and improve the quality management systems adaptive to 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. | | 第二十四条 医疗器械生产企业应当按照医疗器械生产质量管理规范的要求，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 production enterprises shall conduct self-inspection on the operation of the quality management system on a regular basis, and submit the self-inspection reports to the food and drug supervision and administration departments of the local people's governments of provinces, autonomous regions or municipalities directly under the Central Government. | | 医疗器械生产企业应当定期对质量管理体系的运行情况进行自查，并向所在地省、自治区、直辖市人民政府食品药品监督管理部门提交自查报告。 |
| Article 25 Where the production conditions of medical device production enterprises change and no longer meet the requirements for the medical device quality management system, medical device 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 food and drug supervision and administration departments of the local people's governments at the county level. | | 第二十五条 医疗器械生产企业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，并向所在地县级人民政府食品药品监督管理部门报告。 |
| Article 26 The medical devices shall have generic names. Generic names shall comply with the naming rules for medical devices formulated by the food and drug supervision and administration department of the State Council. | | 第二十六条 医疗器械应当使用通用名称。通用名称应当符合国务院食品药品监督管理部门制定的医疗器械命名规则。 |
| Article 27 The medical devices shall be attached with instructions and labels. The contents of instructions and labels shall keep consistent with the relevant contents subject to registration or recordation. | | 第二十七条 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。 |
| The instruction and label of a medical device shall indicate the following items: | | 医疗器械的说明书、标签应当标明下列事项： |
| (1) Generic name, model and specification. | | （一）通用名称、型号、规格； |
| (2) The name and domicile, production address and contact information of the production enterprise. | | （二）生产企业的名称和住所、生产地址及联系方式； |
| (3) The serial number of product technical requirements. | | （三）产品技术要求的编号； |
| (4) Production date and service life or expiration date. | | （四）生产日期和使用期限或者失效日期； |
| (5) Product's performance, main structure and scope of application. | | （五）产品性能、主要结构、适用范围； |
| (6) Contraindications, matters for attention, and other warnings or tips. | | （六）禁忌症、注意事项以及其他需要警示或者提示的内容； |
| (7) Instructions for installation and use and the drawings thereof. | | （七）安装和使用说明或者图示； |
| (8) Product maintenance methods, and special storage conditions and methods. | | （八）维护和保养方法，特殊储存条件、方法； |
| (9) Other contents that shall be indicated as prescribed in the production technical requirements. | | （九）产品技术要求规定应当标明的其他内容。 |
The serial numbers of medical device registration certificates and medical device registrants' names, addresses and contact information shall also be indicated in the instructions and labels of medical devices of Class II and Class III.
．．．．．． | | 第二类、第三类医疗器械还应当标明医疗器械注册证编号和医疗器械注册人的名称、地址及联系方式。
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