医疗器械监督管理条例

Regulations on Supervision and Administration of Medical Devices

(2017年版)

(Version 2017)

（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）

(Promulgated by the 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; and revised in accordance with the Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices on May 4, 2017)

第一章 总 则

Chapter I        General Provisions

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 1 These Regulations are formulated in order to protect the safety and effectiveness of medical devices and safeguard the physical health and life safety of the public.

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 2 Any organization or individual engaged in the research, manufacture, operation, use, supervision and administration of medical devices within the territory of the People’s Republic of China shall abide by these Regulations.

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。

Article 3 The Food and Drug 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 scopes of responsibility.

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 Administration Departments of the various 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 scopes of responsibility.

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。

The Food and Drug Administration Department of the State Council shall cooperate with relevant departments of the State Council to carry out and implement the planning for and policies on the medical devices industry.

第四条 国家对医疗器械按照风险程度实行分类管理。

Article 4 The state shall conduct the classification administration of medical devices according to their risk levels.

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。

The medical devices with lower risks are categorized as Class I medical devices; their safety and effectiveness can be guaranteed by implementing general management.

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。

The medical devices with moderate risks are categorized as Class II medical devices; their safety and effectiveness can be guaranteed by implementing stricter management.

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 medical devices with higher risks are categorized as Class III medical devices; their safety and effectiveness can be guaranteed by taking special measures and by stricter management.

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。

When evaluating the risks of any medical devices, their intended use, structural feature, method of application and other factors must be taken into account.

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。

The Food and Drug Administration Department of the State Council shall be responsible for formulating the classification rules and Classified Catalogue for medical devices, and shall, depending on the production, operation and application of medical devices, analyze and evaluate their risk changes in a timely manner and then adjust the Classified Catalogue. When formulating and adjusting the Classified Catalogue, the Food and Drug Administration Department of the State Council shall fully listen to the opinions of the medical device manufacturers, operators, users, and industrial organizations, and consult international classification practices of medical devices. The Classified Catalogues of medical devices shall be made public.

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 5 The research and manufacture of medical devices shall follow the principles of safety, effectiveness and cost conservation. 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。

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 6 Medical device products shall comply with the compulsory national standards for medical devices. If there are no national standards, the compulsory industrial standards for medical devices shall be adopted.

The catalogue of single-use medical devices shall be formulated, adjusted and published by the Food and Drug Administration Department of the State Council jointly with the Health and Family Planning Administration Department 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. Any medical devices whose safety and effectiveness can be ensured in case of reuse after having their designs, production processes, disinfection and sterilization technologies improved shall be removed from the catalogue of single-use medical devices.

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。

Article 7 Medical device industrial organizations shall strengthen industrial self-discipline, promote the construction of the credit system, urge enterprises to conduct production and operation activities according to law, and guide enterprises to be honest and trustworthy.

第二章 医疗器械产品注册与备案

Chapter II       Registration and Filing of Medical Device Products

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 8 The Class I medical devices shall be subject to the product filing administration, and the Class II and Class III medical devices shall be subject to the product registration administration.

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：

（一）产品风险分析资料；

（二）产品技术要求；

（三）产品检验报告；

（四）临床评价资料；

（五）产品说明书及标签样稿；

（六）与产品研制、生产有关的质量管理体系文件；

（七）证明产品安全、有效所需的其他资料。

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 9 The following materials shall be submitted for the filing of Class I medical device products and the application for registration of the medical device product of Class II and Class III:

(a) Product risk analysis materials;

(b) Product technical requirements;

(c) Product inspection report;

(d) Clinical evaluation materials;

(e) Product instruction and label sample;

(f) Quality assurance system documents related to product research and manufacture and production;

(g) Other materials necessary for demonstrating the safety and effectiveness of the medical device.

Applicants of registration and filing of medical devices shall be responsible for the authenticity of the materials submitted.

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。

Article 10 For the filing of medical device products of Class I, the filing applicant shall submit filing materials to the Food and Drug Administration Department of the people’s governments of the local municipalities with districts. The product inspection reports thereof may be self-inspection reports from the filing applicant, and the clinical evaluation materials thereof shall 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 applications of similar products.

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。

An overseas manufacturer exporting Class I medical devices to the territory of the People’s Republic of China shall, through its representative office established within the territory of the People’s Republic of China or the business entity designated within the territory of the People’s Republic of China as the agent, submit to the Food and Drug Administration Department of the State Council the filing materials and the evidential document of approval for marketing of the medical device issued by the competent department of the country (region) where the filing applicant is located.

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。

In case of any change to the matters specified in the filing materials, the filing applicant shall apply for the filing of change with the original filing department.

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。

Article 11 For the application for the registration of medical device products of Class II, registration applicants shall submit registration materials to the Food and Drug Administration Department of the people’s governments of the provinces, autonomous regions, or municipalities directly under the Central Government where the applicants are located. For the application for registration of medical device products of Class III, registration applicants shall submit registration materials to the Food and Drug Administration Department of the State Council.

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。

An overseas manufacturer exporting medical devices of Class II and Class III to the territory of the People’s Republic of China, shall through its representative office established within the territory of the People’s Republic of China or the business entity designated within the territory of the People’s Republic of China as its agent, submit to the Food and Drug Administration Department of the State Council the registration materials and the evidential documents of approval for marketing of the medical device issued by the competent department of the country (region) where the registration applicant is located.

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。

The product inspection reports amid the application materials for the registration of the medical device products of Class II and Class III shall be inspection reports issued by the medical device inspection institutions. Clinical evaluation materials shall include clinical trial reports, except for medical devices exempted from clinical trial according to Article 17 of these Regulations.

……

……

……

……

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：

Article 17 Clinical trials are not required for the filing of Class I medical devices, but are required for the application for registration of Class II and Class III medical devices. In any of the following cases, however, clinical trials may be exempted:

（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；

（二）通过非临床评价能够证明该医疗器械安全、有效的；

（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。

(a) Marketed medical devices of the same category 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.

(b) The safety and effectiveness of the medical device can be proved through non-clinical evaluation;

(c) 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 medical devices of the same category.

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。

The catalogue of the medical devices exempt from clinical trials shall be formulated, adjusted and published by the Food and Drug Administration Department of the State Council.

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，在具备相应条件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。

Article 18 Clinical trials for a medical devices shall be executed by a qualified clinical trial institution in compliance with the Specifications for Quality Control of Clinical Trials for Medical Devices and shall be reported for filing to the Food and Drug Administration Department of the people's government of the province, autonomous region or municipality directly under the Central Government where the clinical trial presenter is located. The Food and Drug Administration Department accepting the filing of the clinical trial shall notify the filing situation to the Food and Drug Administration Department and the Health and Family Planning Administration Department of the same level where the clinical trial institution is located.

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及备案管理办法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。

Medical device clinical trial institutions shall be subject to filing administration. The conditions that a medical device clinical trial institution shall satisfy, the administrative filing measures and the specifications for quality control of clinical trials shall be developed and published by the Food and Drug Administration Department of the State Council in conjunction with the Health and Family Planning 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。

Article 19 Clinical trials for Class III medical devices that pose relatively high risk to human body shall be approved by the Food and Drug Administration Department of the State Council. The catalogue of Class III medical devices that pose relatively high risk to human body during clinical trials shall be formulated, adjusted, and published by the Food and Drug Administration Department of the State Council.

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。

When examining and approving clinical trials, the Food and Drug Administration Department of the State Council shall comprehensively analyze the conditions (equipment, professionals, etc.) of the institution undertaking the clinical trial, the risk level of the medical device, the implementation scheme of the clinical trial, the clinical benefit risk assessment report and so on. The approval of a clinical trial shall be notified to the clinical trial presenter, the Food and Drug Administration Department and the Health and Family Planning Administration Department of the people's government of the province, autonomous region or municipality directly under the Central Government where the clinical trial institution is located.

第三章 医疗器械生产

Chapter III     Production of Medical Devices

第二十条 从事医疗器械生产活动，应当具备下列条件：

（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；

（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；

（三）有保证医疗器械质量的管理制度；

（四）有与生产的医疗器械相适应的售后服务能力；

（五）产品研制、生产工艺文件规定的要求。

Article 20 Those to produce medical devices shall meet the following requirements:

(a) Have the production site, environmental conditions, production equipment and professionals appropriate to the production of the medical device;

(b) Have the institutions or full-time inspection personnel and the inspection equipment for the quality inspection of the medical device produced;

(c) Have the quality assurance system to ensure the quality of the medical device;

(d) Have the after-sales service capability appropriate to the manufactured medical device;

(e) Meet the requirements as prescribed in the product development and manufacturing process documents.

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 21 A manufacturer engaging in the manufacturing of Class I medical devices shall submit a filing application and certification documents meeting the requirements set forth in Article 20 of these Regulations to the Food and Drug Administration Department of the municipal-level of the region where it is located.

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。

Article 22 A manufacturer engaging in the manufacturing of Class II and Class III medical devices shall apply for production permit with the Food and Drug Administration Department of the people’s government of the province, autonomous region or municipality directly under the Central Government where it is located and submit certification documents meeting the requirements set forth in Article 20 of these Regulations and the registration certificate of the medical device manufactured.

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。

The Food and Drug Administration Department accepting the application for production permit shall review the application documents within 30 working days from the date of acceptance, and conduct verification and examination in accordance with Specifications for Production Quality Assurance of Medical Devices. If the specified requirements are met, a production permit for the medical device shall be approved and issued; if the requirements are not met, no permit will be issued and the reasons shall be stated in writing.

……

……

……

……

第五十六条 食品药品监督管理部门应当加强对医疗器械生产经营企业和使用单位生产、经营、使用的医疗器械的抽查检验。抽查检验不得收取检验费和其他任何费用，所需费用纳入本级政府预算。省级以上人民政府食品药品监督管理部门应当根据抽查检验结论及时发布医疗器械质量公告。

Article 56 The Food and Drug Administration Department shall strengthen sampling inspection on all medical devices manufactured, operated, and used by medical device manufacturers, operators and users. No inspection fee or other expense shall be charged for such sampling inspection but all the expenses arising thereof shall be disbursed from the financial budget of the government at the same level. The food and drug administration departments of the people’s governments at or above the level of province shall timely publicize medical device quality announcements according to the conclusions of the sampling inspections.

卫生计生主管部门应当对大型医用设备的使用状况进行监督和评估；发现违规使用以及与大型医用设备相关的过度检查、过度治疗等情形的，应当立即纠正，依法予以处理

The Health and Family Planning Administration Department shall supervise and evaluate the use of large medical devices. In case of illegal use of a large medical device or large medical device related excessive testing or therapy, immediate rectification and punishment shall be carried out according to law.

第五十七条 医疗器械检验机构资质认定工作按照国家有关规定实行统一管理。经国务院认证认可监督管理部门会同国务院食品药品监督管理部门认定的检验机构，方可对医疗器械实施检验。

Article 57             The State shall implement a uniform qualification authentication system for medical device inspection institutions. Only the inspection institutions recognized by the Certification and Accreditation Administration Department of the State Council and the Food and Drug Administration Department of the State Council can carry out inspections on medical devices.

食品药品监督管理部门在执法工作中需要对医疗器械进行检验的，应当委托有资质的医疗器械检验机构进行，并支付相关费用。

If the Food and Drug Administration Department needs to conduct inspection on medical devices during the law enforcement, it shall entrust a medical device inspection institutions with accreditation to conduct the inspection and pay relevant expenses.

当事人对检验结论有异议的，可以自收到检验结论之日起7个工作日内选择有资质的医疗器械检验机构进行复检。承担复检工作的医疗器械检验机构应当在国务院食品药品监督管理部门规定的时间内作出复检结论。复检结论为最终检验结论。

If the party concerned has any objection against the inspection conclusion, it may choose a qualified medical device inspection institutions for re-inspection within 7 working days after receiving the inspection conclusion. The medical device inspection institutions undertaking the re-inspection shall provide re-inspection conclusion within the time specified by the Food and Drug Administration Department of the State Council. The re-inspection conclusions shall be final.

第五十八条 对可能存在有害物质或者擅自改变医疗器械设计、原材料和生产工艺并存在安全隐患的医疗器械，按照医疗器械国家标准、行业标准规定的检验项目和检验方法无法检验的，医疗器械检验机构可以补充检验项目和检验方法进行检验；使用补充检验项目、检验方法得出的检验结论，经国务院食品药品监督管理部门批准，可以作为食品药品监督管理部门认定医疗器械质量的依据。

Article 58 For any medical device possibly containing harmful substance or those with altered unauthorized design, raw materials, or production process and those with hidden safety problems, if the inspection cannot be conducted through the inspection items and inspection methods as specified in the national standard and industrial standard for medical devices, the medical device inspection institution may use appropriate supplementary inspection items and methods for inspection. The inspection results obtained by using supplementary inspection items and methods, if approved by the food and drug administration department of the state council, may be used as the basis for the Food and Drug Administration Department to judge the quality of the medical device.

第五十九条 设区的市级和县级人民政府食品药品监督管理部门应当加强对医疗器械广告的监督检查；发现未经批准、篡改经批准的广告内容的医疗器械广告，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报告，由其向社会公告。

Article 59 The food and drug administration departments of the people’s government at the level of county and municipality with districts shall strengthen the supervision and inspection on medical device advertisements. Any medical device advertisement not being approved or with the content modified without authorization shall be reported to the Food and Drug Administration Department of the local people’s government of the province, autonomous region or municipality directly under the Central Government, while being publicized to the public.

工商行政管理部门应当依照有关广告管理的法律、行政法规的规定，对医疗器械广告进行监督检查，查处违法行为。食品药品监督管理部门发现医疗器械广告违法发布行为，应当提出处理建议并按照有关程序移交所在地同级工商行政管理部门。

Industrial and commercial administration departments shall supervise and check any medical device advertising activities according to the relevant laws and administrative rules on advertisements and investigate and punish any illegal acts. If any illegal advertising act pertaining to medical devices is found, the food and drug administration department shall immediately put forward punishment suggestions and submit it to the local industrial and commercial administration department at the same level according to relevant procedures.

第六十条 国务院食品药品监督管理部门建立统一的医疗器械监督管理信息平台。食品药品监督管理部门应当通过信息平台依法及时公布医疗器械许可、备案、抽查检验、违法行为查处情况等日常监督管理信息。但是，不得泄露当事人的商业秘密。

Article 60             The Food and Drug Administration Department of the State Council shall establish uniform medical device supervision and management information platform. The Food and Drug Administration Department shall publicize routine supervision and administration information relating to licensing, filing, sampling inspection and illegal acts in connection with medical devices in a timely manner through the information platforms according to law. However, no business secret of the party concerned shall be disclosed.

食品药品监督管理部门对医疗器械注册人和备案人、生产经营企业、使用单位建立信用档案，对有不良信用记录的增加监督检查频次。

The Food and Drug Administration Department shall establish a credit system for registration applicants, filing applicants, manufacturers, operators and users of medical devices and increase the supervision and inspection frequency on those with bad credit records.

……

……

……

……

第七十三条 食品药品监督管理部门、卫生计生主管部门及其工作人员应当严格依照本条例规定的处罚种类和幅度，根据违法行为的性质和具体情节行使行政处罚权，具体办法由国务院食品药品监督管理部门、卫生计生主管部门依据各自职责制定。

Article 73 The Food and Drug Administration Department and its staff shall exercise their authority in administrative penalty strictly in accordance with the punishment types and severity specified in these Regulations and appropriately to the nature of the illegal behavior and specific details. The specific measures shall be formulated by the Food and Drug Administration Department and the Health and Family Planning Administration Department of the State Council according to their respective functions.

第七十四条 违反本条例规定，县级以上人民政府食品药品监督管理部门或者其他有关部门不履行医疗器械监督管理职责或者滥用职权、玩忽职守、徇私舞弊的，由监察机关或者任免机关对直接负责的主管人员和其他直接责任人员依法给予警告、记过或者记大过的处分；造成严重后果的，给予降级、撤职或者开除的处分。

Article 74 In case that any provisions of these Regulations are violated and that the Food and Drug Administration Department of the people’s government at or above the level of county or other relevant departments fail in carrying out their responsibilities in supervision and administration of medical devices, or abuse their power, neglect their duties, and commit irregularities, the person(s) in charge and other direct responsible persons shall be punished by the supervisory organ or the office in charge of appointment and removal according to law. The punishments may include a warning, a demerit recording or a severe demerit recording; in case of gross consequences, punishment such as demotion, dismissal or removal shall be imposed.

第七十五条 违反本条例规定，构成犯罪的，依法追究刑事责任；造成人身、财产或者其他损害的，依法承担赔偿责任。

Article 75 If violation of any provisions of these Regulations constitutes a crime, a criminal sanction shall be imposed according to law; in case of personal injuries, property damages or other damages, the person violating these Regulations shall bear the responsibility for compensation.

第八章 附 则

Chapter VIII  Supplementary Provisions

第七十六条 本条例下列用语的含义：

医疗器械，是指直接或者间接用于人体的仪器、设备、器具、体外诊断试剂及校准物、材料以及其他类似或者相关的物品，包括所需要的计算机软件；其效用主要通过物理等方式获得，不是通过药理学、免疫学或者代谢的方式获得，或者虽然有这些方式参与但是只起辅助作用；其目的是：

Article 76 The terms referred in these Regulations shall have the following meanings:

Medical device refers to instruments, equipment, appliances, in vitro diagnostic reagents or calibrators, materials, and other similar or relevant articles directly or indirectly contacting human body, including necessary computer software, whose effects are achieved mainly by physical means instead of pharmacological, metabolic or immunological means or merely play a subsidiary role by such means and whose purpose mainly is for:

（一）疾病的诊断、预防、监护、治疗或者缓解；

（二）损伤的诊断、监护、治疗、缓解或者功能补偿；

（三）生理结构或者生理过程的检验、替代、调节或者支持；

（四）生命的支持或者维持；

（五）妊娠控制；

（六）通过对来自人体的样本进行检查，为医疗或者诊断目的提供信息。

(a) Diagnosis, prevention, monitoring, treatment or alleviation of disease;

(b) Diagnosis, monitoring, treatment, relief and functional compensation of injury;

(c) Examination, substitution, adjustment or support of physiological structure or physiological process;

(d) Supporting or sustaining life;

(e) Gestation control;

(f) Providing information for medical treatment or diagnosis through examination on samples from human body.

医疗器械使用单位，是指使用医疗器械为他人提供医疗等技术服务的机构，包括取得医疗机构执业许可证的医疗机构，取得计划生育技术服务机构执业许可证的计划生育技术服务机构，以及依法不需要取得医疗机构执业许可证的血站、单采血浆站、康复辅助器具适配机构等。

Medical device user refers to institutions or individuals that use medical devices to provide such technical services as medical treatment to others, including medical institutions that have obtained the Medical Institution Practicing License, family planning related technical service institutions that have obtained the Family Planning Related Technical Service Institution Practicing License, and blood station, single plasma station, rehabilitation supporting device fitting institution and others that do not need to obtain Medical Institution Practicing License.

大型医用设备，是指使用技术复杂、资金投入量大、运行成本高、对医疗费用影响大且纳入目录管理的大型医疗器械。

Large Medical Device refers to large-sized medical devices involving complex technology, high capital investment, high operating costs, and high impact on medical expenses which are included in the catalogue of large medical devices for administration.

第七十七条 医疗器械产品注册可以收取费用。具体收费项目、标准分别由国务院财政、价格主管部门按照国家有关规定制定。

Article 77 Appropriate fees may be charged for registration of medical devices. The specific charging items and criteria shall be established by the competent financial department and/or pricing department of the State Council according to relevant regulations of the State.

第七十八条 非营利的避孕医疗器械管理办法以及医疗卫生机构为应对突发公共卫生事件而研制的医疗器械的管理办法，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。

Article 78 The administrative measures for non-profiting contraceptive medical devices and the administrative measures for medical devices used to respond to sudden public health events shall be formulated by the Food and Drug Administration Department of the State Council together with the Health and Family Planning Administration Department of the State Council.

中医医疗器械的管理办法，由国务院食品药品监督管理部门会同国务院中医药管理部门依据本条例的规定制定；康复辅助器具类医疗器械的范围及其管理办法，由国务院食品药品监督管理部门会同国务院民政部门依据本条例的规定制定。

The administrative measures for medical devices in connection with Chinese traditional medicine shall be formulated jointly by the Food and Drug Administration Department and the Chinese Medicine Administration Department of the State Council according to these Regulations; the scope and administrative measures for auxiliary rehabilitation devices shall be formulated by the Food and Drug Administration Department jointly with the Civil Administration Department of the State Council according to these Regulations.

第七十九条 军队医疗器械使用的监督管理，由军队卫生主管部门依据本条例和军队有关规定组织实施。

Article 79 The administrative measures for military medical device shall be formulated and implemented by the Military Health Administration Department according to these Regulations and relevant military regulations.

第八十条 本条例自2014年6月1日起施行。

Article 80 These Regulations shall come into effect as of June 1, 2014.