Regulation on the Supervision and Administration of Medical Devices

(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》第一次修订　2020年12月21日国务院第119次常务会议修订通过　根据2024年12月6日《国务院关于修改和废止部分行政法规的决定》第二次修订)

(Promulgated by Decree 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; first amended in accordance with the Decision of the State Council on Amending the Regulation on the Supervision and Administration of Medical Devices on May 4, 2017; revised and adopted at the 119th executive meeting of the State Council on December 21, 2020; second amended in accordance with the Decision of the State Council on Amending and Abolishing Certain Administrative Regulations on December 6, 2024)

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。

This Regulation is formulated to ensure the safety and effectiveness of medical devices, protect human health and life safety, and promote the development of the medical device industry.

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。

This Regulation applies to the development, production, operation, and use of medical devices and their supervision and administration within the territory of the People's Republic of China.

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 drug regulatory authority of the State Council shall be responsible for the supervision and administration of medical devices nationwide.

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 relevant departments of the State Council 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。

Local people's governments at or above the county level shall strengthen leadership over the supervision and administration of medical devices within their administrative regions, organize and coordinate the supervision and administration of medical devices and emergency response within their administrative regions, strengthen the capacity building for medical device supervision and administration, and provide guarantees for medical device safety.

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。

The drug regulatory departments of local people's governments at or above the county level shall be responsible for the supervision and administration of medical devices within their administrative regions. The relevant departments of 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.

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。

The supervision and administration of medical devices shall follow the principles of risk management, full-process control, scientific supervision, and social co-governance.

国家对医疗器械按照风险程度实行分类管理。

The state implements classified management of medical devices according to the degree of risk.

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。

Class I refers to medical devices with low risk, whose safety and effectiveness can be ensured through routine 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。

Class II refers to medical devices with moderate risk, which require strict control management 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。

Class III refers to medical devices with high risk, which require special measures for strict control management to ensure their safety and effectiveness.

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 degree of risk of a medical device, factors such as the intended purpose, structural characteristics, and method of use of the medical device shall be considered.

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。

The drug regulatory authority of the State Council shall be responsible for formulating the classification rules and classification catalog for medical devices, and based on the production, operation, and use of medical devices, promptly analyze and evaluate changes in the risk of medical devices, and adjust the classification rules and classification catalog. When formulating and adjusting the classification rules and classification catalog, the opinions of medical device registrants, filing persons, production and operation enterprises, as well as user units and industry organizations, shall be fully solicited, and international medical device classification practices shall be referenced. The classification rules and classification catalog for medical devices shall be published to the public.

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。

Medical device products shall comply with mandatory national standards for medical devices; where there are no mandatory national standards, they shall comply with mandatory industry standards for medical devices.

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。

The state shall formulate industrial development plans and policies for medical devices, include medical device innovation as a development priority, grant priority review and approval to 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 drug regulatory authority of the State Council shall cooperate with the relevant departments of the State Council to implement the national medical device industry plans and guiding policies.

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。

The state shall improve the medical device innovation system, support basic research and applied research on medical devices, promote the promotion and application of new medical device technologies, and provide support in terms of scientific project establishment, financing, credit, bidding and procurement, and medical insurance. It shall support enterprises in establishing or jointly establishing research and development institutions, encourage enterprises to cooperate with higher education institutions, research institutes, medical institutions, etc., in the research and innovation of medical devices, strengthen the protection of intellectual property rights in medical devices, and enhance the independent innovation capability of medical devices.

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。

The state shall strengthen the informatization construction of medical device supervision and administration, improve the level of online government services, and provide convenience for medical device administrative licensing and filing.

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。

Medical device industry organizations shall strengthen industry self-discipline, promote the construction of a credit system, urge enterprises to carry out production and operation activities in accordance with the law, and guide enterprises to be honest and trustworthy.

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。

Units and individuals that have made outstanding contributions to the research and innovation of medical devices shall be commended and rewarded in accordance with relevant state regulations.

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。

Class I medical devices shall be subject to product filing management, while Class II and Class III medical devices shall be subject to product registration management.

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。

Medical device registrants and filing persons shall strengthen the quality management of the entire life cycle of medical devices and bear responsibility for the safety and effectiveness of medical devices throughout the entire process of development, production, operation, and use in accordance with the law.

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：

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

(一)产品风险分析资料；

(1) Product risk analysis materials;

(二)产品技术要求；

(2) Product technical requirements;

(三)产品检验报告；

(3) Product inspection report;

(四)临床评价资料；

(4) Clinical evaluation materials;

(五)产品说明书以及标签样稿；

(5) Product instructions and label samples;

(六)与产品研制、生产有关的质量管理体系文件；

(6) Quality management system documents related to product development and production;

(七)证明产品安全、有效所需的其他资料。

(7) Other materials required to prove the safety and effectiveness of the product.

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。

The product inspection report shall meet the requirements of the drug regulatory authority of the State Council and may be a self-inspection report of the medical device registration applicant or filing person, or an inspection report issued by a qualified medical device inspection institution.

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。

If the circumstances for exemption from clinical evaluation as specified in Article 24 of this Regulation are met, clinical evaluation materials may be exempted from submission.

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。

Medical device registration applicants and filing persons shall ensure that the submitted materials are lawful, truthful, accurate, complete, and traceable.

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。

For the filing of Class I medical device products, the filing person shall submit the filing materials to the drug regulatory department of the people's government at the city divided into districts level where it 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。

For overseas filing persons exporting Class I medical devices to China, the enterprise legal person designated by them within China shall submit the filing materials and the certificate from the competent authority of the country (region) where the filing person is located permitting the marketing of the medical device to the drug regulatory authority of the State Council. For innovative medical devices not marketed overseas, the certificate from the competent authority of the country (region) where the filing person is located permitting the marketing of the medical device may not be submitted.

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。

The filing is completed upon submission of the filing materials that comply with this Regulation to the drug regulatory department. The drug regulatory department shall, within 5 working days from receipt of the filing materials, publish the filing information to the public through the online government service platform of the drug regulatory authority of the State Council.

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。

If the matters stated in the filing materials change, the filing shall be amended with the original filing department.

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。

To apply for registration of a Class II medical device product, the registration applicant shall submit the registration application materials to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located. To apply for registration of a Class III medical device product, the registration applicant shall submit the registration application materials to the drug regulatory authority of the State Council.

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。

For overseas registration applicants exporting Class II or Class III medical devices to China, the enterprise legal person designated by them within China shall submit the registration application materials and the certificate from the competent authority of the country (region) where the registration applicant is located permitting the marketing of the medical device to the drug regulatory authority of the State Council. For innovative medical devices not marketed overseas, the certificate from the competent authority of the country (region) where the registration applicant is located permitting the marketing of the medical device may not be submitted.

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。

The drug regulatory authority of the State Council shall stipulate the procedures and requirements for medical device registration review and strengthen supervision and guidance over the registration review work of the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government.

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 drug regulatory department that accepts the registration application shall review the safety and effectiveness of the medical device and the quality management capability of the registration applicant to ensure the safety and effectiveness of the medical device.

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。

The drug regulatory department that accepts the registration application shall, within 3 working days from the date of acceptance, forward the registration application materials to the technical review institution. The technical review institution shall, after completing the technical review, submit the review opinion to the drug regulatory department that accepted the registration application as the basis for approval.

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。

If the drug regulatory department that accepted the registration application deems it necessary to verify the quality management system during the technical review of the medical device, 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 drug regulatory department that accepted the registration application shall make a decision within 20 working days from the date of receipt of the review opinion. If the conditions are met, it shall grant registration and issue a medical device registration certificate; if the conditions are not met, it shall refuse registration and provide a written explanation.

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。

The drug regulatory department that accepted the registration application shall, within 5 working days from the date of granting registration, publish the registration information to the public through the online government service platform of the drug regulatory authority of the State Council.

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。

For medical devices urgently needed for the treatment of rare diseases, diseases that are seriously life-threatening and for which there is no effective treatment, and for responding to public health events, the drug regulatory department that accepted the registration application may make a conditional approval decision and specify the relevant matters in the medical device registration certificate.

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、国务院疾病预防控制部门根据预防、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。

In the event of an exceptionally major public health emergency or other emergency that seriously threatens public health, the health authority of the State Council and the disease prevention and control department of the State Council may, based on the needs of prevention and control, propose the emergency use of medical devices. After the drug regulatory authority of the State Council organizes demonstration and approval, such medical devices may be used urgently within a certain scope and period.

医疗器械注册人、备案人应当履行下列义务：

Medical device registrants and filing persons shall fulfill the following obligations:

(一)建立与产品相适应的质量管理体系并保持有效运行；

(1) Establish a quality management system suitable for the product and maintain its effective operation;

(二)制定上市后研究和风险管控计划并保证有效实施；

(2) Formulate a post-market research and risk control plan and ensure its effective implementation;

(三)依法开展不良事件监测和再评价；

(3) Carry out adverse event monitoring and re-evaluation in accordance with the law;

(四)建立并执行产品追溯和召回制度；

(4) Establish and implement a product traceability and recall system;

(五)国务院药品监督管理部门规定的其他义务。

(5) Other obligations stipulated by the drug regulatory authority of the State Council.

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。

The enterprise legal person designated by an overseas medical device registrant or filing person within China shall assist the registrant or filing person in fulfilling the obligations specified in the preceding paragraph.

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。

For registered Class II and Class III medical device products, if there are substantive changes in design, raw materials, production process, scope of application, method of use, etc., that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for change registration; for other changes, filing or reporting shall be carried out in accordance with the provisions of the drug regulatory authority of the State Council.

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。

The validity period of a medical device registration certificate is 5 years. If renewal of registration is needed upon expiration, an application for renewal shall be submitted to the original registration department 6 months before the expiration of the validity period.

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。

Except for the circumstances specified in paragraph 3 of this Article, the drug regulatory department that receives the renewal application shall make a decision to grant renewal before the expiration of the medical device registration certificate. If no decision is made within the time limit, it shall be deemed as granting renewal.

有下列情形之一的，不予延续注册：

Renewal of registration shall not be granted in any of the following circumstances:

(一)未在规定期限内提出延续注册申请；

(1) The application for renewal of registration is not submitted within the prescribed time limit;

(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；

(2) The mandatory standards for medical devices have been revised, and the medical device applying for renewal of registration cannot meet the new requirements;

(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。

(3) For conditionally approved medical devices, the matters specified in the medical device registration certificate have not been completed within the prescribed time limit.

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 newly developed medical devices that are not yet included in the classification catalog, the applicant may directly apply for product registration in accordance with the provisions of this Regulation concerning the registration of Class III medical device products, or may determine the product category based on the classification rules and apply for product registration or product filing in accordance with the provisions of this Regulation after applying to the drug regulatory authority of the State Council for category confirmation.

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。

If directly applying for registration of a Class III medical device product, the drug regulatory authority of the State Council shall determine the category based on the degree of risk and promptly include the approved medical device in the classification catalog. If applying for category confirmation, the drug regulatory authority of the State Council shall determine the category of the medical device within 20 working days from the date of acceptance of the application and inform the applicant.

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：

Clinical evaluation shall be conducted for the registration or filing of medical device products; however, clinical evaluation may be exempted in any of the following circumstances:

(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；

(1) The working mechanism is clear, the design is finalized, the production process is mature, the same variety of medical devices already on the market have been used clinically for many years without records of serious adverse events, and the conventional use is not changed;

(二)其他通过非临床评价能够证明该医疗器械安全、有效的。

(2) Other circumstances where the safety and effectiveness of the medical device can be demonstrated through non-clinical evaluation.

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。

The drug regulatory authority of the State Council shall formulate clinical evaluation guidelines for medical devices.

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。

When conducting clinical evaluation of a medical device, based on product characteristics, clinical risks, existing clinical data, etc., the safety and effectiveness of the medical device may be demonstrated by conducting clinical trials or by analyzing and evaluating clinical literature data and clinical data of the same variety of medical devices.

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。

In accordance with the provisions of the drug regulatory authority of the State Council, if existing clinical literature data and clinical data are insufficient to confirm the safety and effectiveness of the product during clinical evaluation, clinical trials shall be conducted.

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。

When conducting clinical trials of medical devices, they shall be carried out in clinical trial institutions with appropriate conditions in accordance with the requirements of the quality management standards for medical device clinical trials, and shall be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the clinical trial sponsor is located. The drug regulatory department that accepts the clinical trial filing shall notify the drug regulatory department and the health authority at the same level where the clinical trial institution is located of the filing.

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。

Medical device clinical trial institutions shall be subject to filing management. The conditions that medical device clinical trial institutions shall meet, as well as the filing management measures and quality management standards for clinical trials, shall be formulated and published by the drug regulatory authority of the State Council jointly with the health authority of the State Council.

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。

The state supports medical institutions in conducting clinical trials, includes the evaluation of clinical trial conditions and capabilities in the hierarchical review of medical institutions, and encourages medical institutions to conduct clinical trials of innovative medical devices.

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。

If clinical trials of Class III medical devices pose a high risk to the human body, approval from the drug regulatory authority of the State Council shall be obtained. When approving clinical trials, the drug regulatory authority of the State Council shall conduct a comprehensive analysis of the equipment and professional personnel of the institution intended to undertake the clinical trial, the degree of risk of the medical device, the clinical trial implementation plan, and the clinical benefit-risk analysis report, and shall make a decision within 60 working days from the date of acceptance of the application and notify the clinical trial sponsor. If no notification is given within the time limit, it shall be deemed as consent. If approval is granted to conduct clinical trials, the drug regulatory department and the health authority of the province, autonomous region, or municipality directly under the Central Government where the clinical trial institution is located shall be notified.

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。

The catalog of Class III medical devices for which clinical trials pose a high risk to the human body shall be formulated, adjusted, and published by the drug regulatory authority of the State Council.

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 conducting clinical trials of medical devices, ethical review shall be carried out in accordance with regulations, and the subjects shall be informed of the purpose, use, and possible risks of the trial in detail, and written informed consent shall be obtained from the subjects; if the subject is a person without civil capacity or with limited civil capacity, written informed consent shall be obtained from their guardian in accordance with the law.

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。

When conducting clinical trials, no fees related to the clinical trial shall be charged to the subjects in any form.

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。

For medical devices being used in ongoing clinical trials for the treatment of seriously life-threatening diseases for which there is no effective treatment, if medical observation indicates that patients may benefit, after ethical review and informed consent, they may be used free of charge for other patients with the same condition within the institution conducting the clinical trial, and the safety data may be used for medical device registration applications.

从事医疗器械生产活动，应当具备下列条件：

To engage in the production of medical devices, the following conditions shall be met:

(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；

(1) Having production sites, environmental conditions, production equipment, and professional technical personnel suitable for the medical devices being produced;

(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；

(2) Having an institution or full-time inspection personnel capable of conducting quality inspection of the medical devices being produced, as well as inspection equipment;

(三)有保证医疗器械质量的管理制度；

(3) Having a management system to ensure the quality of medical devices;

(四)有与生产的医疗器械相适应的售后服务能力；

(4) Having after-sales service capabilities suitable for the medical devices being produced;

(五)符合产品研制、生产工艺文件规定的要求。

(5) Meeting the requirements specified in the product development and production process documents.

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。

To engage in the production of Class I medical devices, the producer shall file with the drug regulatory department of the people's government at the city divided into districts level where it is located, and the filing is completed upon submission of the relevant materials that meet the conditions specified in Article 30 of this Regulation.

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。

If a medical device filing person produces Class I medical devices on its own, it may submit the relevant materials that meet the conditions specified in Article 30 of this Regulation at the same time as filing the product in accordance with Article 15 of this Regulation, thereby completing the production filing.

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。

To engage in the production of Class II or Class III medical devices, the producer shall apply for a production license to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located, and submit the relevant materials that meet the conditions specified in Article 30 of this Regulation and the registration certificate of the medical device being produced.

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。

The drug regulatory department that accepts the production license application shall review the application materials, conduct verification in accordance with the requirements of the quality management standards for medical device production formulated by the drug regulatory authority of the State Council, and make a decision within 20 working days from the date of acceptance. If the conditions are met, it shall grant the license and issue a medical device production license; if the conditions are not met, it shall refuse the license and provide a written explanation.

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。

The validity period of a medical device production license is 5 years. If renewal is needed upon expiration, the renewal procedures shall be handled in accordance with the legal provisions on administrative licensing.

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。

The quality management standards for medical device production shall clearly stipulate matters affecting the safety and effectiveness of medical devices, such as design and development, production equipment conditions, raw material procurement, production process control, product release, and the organizational structure and staffing of the enterprise.

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。

Medical device registrants and filing persons may produce medical devices on their own or entrust production to enterprises that meet the requirements of this Regulation and have appropriate conditions.

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。

When entrusting production of medical devices, the medical device registrant or filing person shall be responsible for the quality of the entrusted medical devices and strengthen the management of the production behavior of the entrusted production enterprise to ensure that it produces in accordance with legal requirements. The medical device registrant or filing person shall sign an entrustment agreement with the entrusted production enterprise, specifying the rights, obligations, and responsibilities of both parties. The entrusted production enterprise shall organize production in accordance with laws and regulations, quality management standards for medical device production, mandatory standards, product technical requirements, and the entrustment agreement, be responsible for the production behavior, and accept the supervision of the entrusting party.

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。

Implantable medical devices with high risk shall not be entrusted for production. The specific catalog shall be formulated, adjusted, and published by the drug regulatory authority of the State Council.

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, filing persons, and entrusted production enterprises shall, in accordance with the quality management standards for medical device production, establish and maintain a quality management system suitable for the medical devices being produced and ensure its effective operation; they shall organize production strictly in accordance with the product technical requirements that have been registered or filed, and ensure that the medical devices leaving the factory comply with mandatory standards and the registered or filed product technical requirements.

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。

Medical device registrants, filing persons, and entrusted production enterprises shall regularly conduct self-inspections of the operation of the quality management system and submit self-inspection reports in accordance with the provisions of the drug regulatory authority of the State Council.

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。

If the production conditions of a medical device change and no longer meet the requirements of the medical device quality management system, the medical device registrant, filing person, or entrusted production enterprise shall immediately take corrective measures; if the safety or effectiveness of the medical device may be affected, it shall immediately stop production activities and report to the original production license or production filing department.

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。

Medical devices shall use common names. The common name shall comply with the medical device naming rules formulated by the drug regulatory authority of the State Council.

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。

The state shall implement a unique device identification system for medical devices step by step according to product categories to achieve traceability of medical devices. Specific measures shall be formulated by the drug regulatory authority of the State Council jointly with the relevant departments of the State Council.

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。

Medical devices shall have instructions and labels. The content of the instructions and labels shall be consistent with the registered or filed content and shall be truthful and accurate.

医疗器械的说明书、标签应当标明下列事项：

The instructions and labels of medical devices shall indicate the following items:

(一)通用名称、型号、规格；

(1) Common name, model, and specification;

(二)医疗器械注册人、备案人、受托生产企业的名称、地址以及联系方式；

(2) The name, address, and contact information of the medical device registrant, filing person, and entrusted production enterprise;

(三)生产日期，使用期限或者失效日期；

(3) Date of manufacture, service life or expiration date;

(四)产品性能、主要结构、适用范围；

(4) Product performance, main structure, and scope of application;

(五)禁忌、注意事项以及其他需要警示或者提示的内容；

(5) Contraindications, precautions, and other content requiring warning or prompting;

(六)安装和使用说明或者图示；

(6) Installation and use instructions or diagrams;

(七)维护和保养方法，特殊运输、贮存的条件、方法；

(7) Maintenance and care methods, special transportation and storage conditions and methods;

(八)产品技术要求规定应当标明的其他内容。

(8) Other content that shall be indicated as required by the product technical requirements.

第二类、第三类医疗器械还应当标明医疗器械注册证编号。

Class II and Class III medical devices shall also indicate the medical device registration certificate number.

由消费者个人自行使用的医疗器械还应当具有安全使用的特别说明。

Medical devices intended for personal use by consumers shall also have special instructions for safe use.

从事医疗器械经营活动，应当有与经营规模和经营范围相适应的经营场所和贮存条件，以及与经营的医疗器械相适应的质量管理制度和质量管理机构或者人员。

To engage in the operation of medical devices, there shall be business premises and storage conditions suitable for the scale and scope of operation, as well as a quality management system and quality management institutions or personnel suitable for the medical devices being operated.

从事第二类医疗器械经营的，由经营企业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并提交符合本条例第四十条规定条件的有关资料。

To engage in the operation of Class II medical devices, the operating enterprise shall file with the drug regulatory department of the people's government at the city divided into districts level where it is located and submit the relevant materials that meet the conditions specified in Article 40 of this Regulation.

按照国务院药品监督管理部门的规定，对产品安全性、有效性不受流通过程影响的第二类医疗器械，可以免于经营备案。

In accordance with the provisions of the drug regulatory authority of the State Council, Class II medical devices whose safety and effectiveness are not affected by the circulation process may be exempted from operation filing.

从事第三类医疗器械经营的，经营企业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申请经营许可并提交符合本条例第四十条规定条件的有关资料。

To engage in the operation of Class III medical devices, the operating enterprise shall apply for an operation license to the drug regulatory department of the people's government at the city divided into districts level where it is located and submit the relevant materials that meet the conditions specified in Article 40 of this Regulation.

受理经营许可申请的负责药品监督管理的部门应当对申请资料进行审查，必要时组织核查，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经营许可证；对不符合规定条件的，不予许可并书面说明理由。

The drug regulatory department that accepts the operation license application shall review the application materials, organize verification if necessary, and make a decision within 20 working days from the date of acceptance. If the conditions are met, it shall grant the license and issue a medical device operation license; if the conditions are not met, it shall refuse the license and provide a written explanation.

医疗器械经营许可证有效期为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。

The validity period of a medical device operation license is 5 years. If renewal is needed upon expiration, the renewal procedures shall be handled in accordance with the legal provisions on administrative licensing.

医疗器械注册人、备案人经营其注册、备案的医疗器械，无需办理医疗器械经营许可或者备案，但应当符合本条例规定的经营条件。

Medical device registrants and filing persons who operate the medical devices they have registered or filed do not need to obtain a medical device operation license or filing, but shall meet the operating conditions specified in this Regulation.

从事医疗器械经营，应当依照法律法规和国务院药品监督管理部门制定的医疗器械经营质量管理规范的要求，建立健全与所经营医疗器械相适应的质量管理体系并保证其有效运行。

Those engaged in the operation of medical devices shall, in accordance with laws and regulations and the requirements of the quality management standards for medical device operation formulated by the drug regulatory authority of the State Council, establish and maintain a quality management system suitable for the medical devices being operated and ensure its effective operation.

医疗器械经营企业、使用单位应当从具备合法资质的医疗器械注册人、备案人、生产经营企业购进医疗器械。购进医疗器械时，应当查验供货者的资质和医疗器械的合格证明文件，建立进货查验记录制度。从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业，还应当建立销售记录制度。

Medical device operating enterprises and user units shall purchase medical devices from medical device registrants, filing persons, and production and operating enterprises with legal qualifications. When purchasing medical devices, they shall verify the qualifications of the supplier and the certificate of conformity of the medical device, and establish a purchase inspection and record system. Operating enterprises engaged in wholesale of Class II and Class III medical devices and retail of Class III medical devices shall also establish a sales record system.

记录事项包括：

The recorded items include:

(一)医疗器械的名称、型号、规格、数量；

(1) The name, model, specification, and quantity of the medical device;

(二)医疗器械的生产批号、使用期限或者失效日期、销售日期；

(2) The production batch number, service life or expiration date, and sales date of the medical device;

(三)医疗器械注册人、备案人和受托生产企业的名称；

(3) The name of the medical device registrant, filing person, and entrusted production enterprise;

(四)供货者或者购货者的名称、地址以及联系方式；

(4) The name, address, and contact information of the supplier or purchaser;

(五)相关许可证明文件编号等。

(5) The relevant license certificate number, etc.

进货查验记录和销售记录应当真实、准确、完整和可追溯，并按照国务院药品监督管理部门规定的期限予以保存。国家鼓励采用先进技术手段进行记录。

Purchase inspection records and sales records shall be truthful, accurate, complete, and traceable, and shall be kept for the period specified by the drug regulatory authority of the State Council. The state encourages the use of advanced technical means for recording.

从事医疗器械网络销售的，应当是医疗器械注册人、备案人或者医疗器械经营企业。从事医疗器械网络销售的经营者，应当将从事医疗器械网络销售的相关信息告知所在地设区的市级人民政府负责药品监督管理的部门，经营第一类医疗器械和本条例第四十一条第二款规定的第二类医疗器械的除外。

Those engaged in the online sale of medical devices shall be medical device registrants, filing persons, or medical device operating enterprises. Operators engaged in the online sale of medical devices shall inform the drug regulatory department of the people's government at the city divided into districts level where they are located of the relevant information on the online sale of medical devices, except for those operating Class I medical devices and Class II medical devices specified in paragraph 2 of Article 41 of this Regulation.

为医疗器械网络交易提供服务的电子商务平台经营者应当对入网医疗器械经营者进行实名登记，审查其经营许可、备案情况和所经营医疗器械产品注册、备案情况，并对其经营行为进行管理。电子商务平台经营者发现入网医疗器械经营者有违反本条例规定行为的，应当及时制止并立即报告医疗器械经营者所在地设区的市级人民政府负责药品监督管理的部门；发现严重违法行为的，应当立即停止提供网络交易平台服务。

E-commerce platform operators providing services for medical device online transactions shall conduct real-name registration of online medical device operators, review their operation licenses, filing status, and the registration or filing status of the medical device products they operate, and manage their business activities. If an e-commerce platform operator discovers that an online medical device operator has violated the provisions of this Regulation, it shall promptly stop it and immediately report to the drug regulatory department of the people's government at the city divided into districts level where the medical device operator is located; if a serious violation is discovered, it shall immediately stop providing online transaction platform services.

运输、贮存医疗器械，应当符合医疗器械说明书和标签标示的要求；对温度、湿度等环境条件有特殊要求的，应当采取相应措施，保证医疗器械的安全、有效。

The transportation and storage of medical devices shall comply with the requirements indicated in the medical device instructions and labels; if there are special requirements for environmental conditions such as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of the medical devices.

医疗器械使用单位应当有与在用医疗器械品种、数量相适应的贮存场所和条件。医疗器械使用单位应当加强对工作人员的技术培训，按照产品说明书、技术操作规范等要求使用医疗器械。

Medical device user units shall have storage premises and conditions suitable for the variety and quantity of medical devices in use. Medical device user units shall strengthen technical training for staff and use medical devices in accordance with the requirements of product instructions and technical operation specifications.

医疗器械使用单位配置大型医用设备，应当符合国务院卫生主管部门制定的大型医用设备配置规划，与其功能定位、临床服务需求相适应，具有相应的技术条件、配套设施和具备相应资质、能力的专业技术人员，并经省级以上人民政府卫生主管部门批准，取得大型医用设备配置许可证。

When configuring large medical equipment, medical device user units shall comply with the large medical equipment configuration plan formulated by the health authority of the State Council, be suitable for their functional positioning and clinical service needs, have corresponding technical conditions, supporting facilities, and professional technical personnel with appropriate qualifications and capabilities, and obtain approval from the health authority at or above the provincial level and obtain a large medical equipment configuration license.

大型医用设备配置管理办法由国务院卫生主管部门会同国务院有关部门制定。大型医用设备目录由国务院卫生主管部门商国务院有关部门提出，报国务院批准后执行。

The measures for the administration of large medical equipment configuration shall be formulated by the health authority of the State Council jointly with the relevant departments of the State Council. The catalog of large medical equipment shall be proposed by the health authority of the State Council in consultation with the relevant departments of the State Council and implemented after approval by the State Council.

医疗器械使用单位对重复使用的医疗器械，应当按照国务院卫生主管部门制定的消毒和管理的规定进行处理。

Medical device user units shall handle reusable medical devices in accordance with the disinfection and management regulations formulated by the health authority of the State Council.

一次性使用的医疗器械不得重复使用，对使用过的应当按照国家有关规定销毁并记录。一次性使用的医疗器械目录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、调整并公布。列入一次性使用的医疗器械目录，应当具有充足的无法重复使用的证据理由。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，允许重复使用。

Single-use medical devices shall not be reused, and used ones shall be destroyed and recorded in accordance with relevant state regulations. The catalog of single-use medical devices shall be formulated, adjusted, and published by the drug regulatory authority of the State Council jointly with the health authority of the State Council. Medical devices included in the single-use medical device catalog shall have sufficient evidence and reasons that they cannot be reused. Medical devices that can be reused while ensuring safety and effectiveness shall not be included in the single-use medical device catalog. Medical devices that can be reused while ensuring safety and effectiveness due to improvements in design, production process, disinfection and sterilization technology, etc., shall be removed from the single-use medical device catalog and allowed to be reused.

医疗器械使用单位对需要定期检查、检验、校准、保养、维护的医疗器械，应当按照产品说明书的要求进行检查、检验、校准、保养、维护并予以记录，及时进行分析、评估，确保医疗器械处于良好状态，保障使用质量；对使用期限长的大型医疗器械，应当逐台建立使用档案，记录其使用、维护、转让、实际使用时间等事项。记录保存期限不得少于医疗器械规定使用期限终止后5年。

Medical device user units shall, for medical devices that require regular inspection, testing, calibration, maintenance, and servicing, carry out inspection, testing, calibration, maintenance, and servicing in accordance with the requirements of the product instructions, record them, and promptly analyze and evaluate them to ensure that the medical devices are in good condition and guarantee the quality of use; for large medical devices with a long service life, a use file shall be established for each device, recording matters such as its use, maintenance, transfer, and actual use time. The retention period of records shall not be less than 5 years after the end of the specified service life of the medical device.

医疗器械使用单位应当妥善保存购入第三类医疗器械的原始资料，并确保信息具有可追溯性。

Medical device user units shall properly keep the original materials of purchased Class III medical devices and ensure the traceability of information.

使用大型医疗器械以及植入和介入类医疗器械的，应当将医疗器械的名称、关键性技术参数等信息以及与使用质量安全密切相关的必要信息记载到病历等相关记录中。

When using large medical devices and implantable and interventional medical devices, information such as the name and key technical parameters of the medical device, as well as necessary information closely related to the quality and safety of use, shall be recorded in medical records and other relevant records.

发现使用的医疗器械存在安全隐患的，医疗器械使用单位应当立即停止使用，并通知医疗器械注册人、备案人或者其他负责产品质量的机构进行检修；经检修仍不能达到使用安全标准的医疗器械，不得继续使用。

If a medical device in use is found to have safety hazards, the medical device user unit shall immediately stop using it and notify the medical device registrant, filing person, or other institution responsible for product quality to carry out repairs; if the medical device still cannot meet the safety standards for use after repairs, it shall not continue to be used.

对国内尚无同品种产品上市的体外诊断试剂，符合条件的医疗机构根据本单位的临床需要，可以自行研制，在执业医师指导下在本单位内使用。具体管理办法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。

For in vitro diagnostic reagents that are not yet available on the domestic market, qualified medical institutions may, based on their clinical needs, develop them on their own and use them within the institution under the guidance of licensed physicians. Specific management measures shall be formulated by the drug regulatory authority of the State Council jointly with the health authority of the State Council.

负责药品监督管理的部门和卫生主管部门依据各自职责，分别对使用环节的医疗器械质量和医疗器械使用行为进行监督管理。

The drug regulatory departments and health authorities shall, based on their respective functions, supervise and manage the quality of medical devices in the use link and the use behavior of medical devices.

医疗器械经营企业、使用单位不得经营、使用未依法注册或者备案、无合格证明文件以及过期、失效、淘汰的医疗器械。

Medical device operating enterprises and user units shall not operate or use medical devices that have not been registered or filed in accordance with the law, lack certificates of conformity, or are expired, invalid, or eliminated.

医疗器械使用单位之间转让在用医疗器械，转让方应当确保所转让的医疗器械安全、有效，不得转让过期、失效、淘汰以及检验不合格的医疗器械。

When transferring medical devices in use between medical device user units, the transferor shall ensure that the transferred medical devices are safe and effective, and shall not transfer expired, invalid, eliminated, or unqualified medical devices.

进口的医疗器械应当是依照本条例第二章的规定已注册或者已备案的医疗器械。

Imported medical devices shall be those that have been registered or filed in accordance with the provisions of Chapter II of this Regulation.

进口的医疗器械应当有中文说明书、中文标签。说明书、标签应当符合本条例规定以及相关强制性标准的要求，并在说明书中载明医疗器械的原产地以及境外医疗器械注册人、备案人指定的我国境内企业法人的名称、地址、联系方式。没有中文说明书、中文标签或者说明书、标签不符合本条规定的，不得进口。

Imported medical devices shall have Chinese instructions and Chinese labels. The instructions and labels shall comply with the provisions of this Regulation and the requirements of relevant mandatory standards, and the instructions shall indicate the origin of the medical device and the name, address, and contact information of the enterprise legal person designated by the overseas medical device registrant or filing person within China. If there are no Chinese instructions or Chinese labels, or if the instructions or labels do not comply with the provisions of this Article, the medical devices shall not be imported.

医疗机构因临床急需进口少量第二类、第三类医疗器械的，经国务院药品监督管理部门或者国务院授权的省、自治区、直辖市人民政府批准，可以进口。进口的医疗器械应当在指定医疗机构内用于特定医疗目的。

If a medical institution urgently needs to import a small quantity of Class II or Class III medical devices for clinical needs, it may import them with the approval of the drug regulatory authority of the State Council or the people's government of the province, autonomous region, or municipality directly under the Central Government authorized by the State Council. The imported medical devices shall be used for specific medical purposes within the designated medical institution.

禁止进口过期、失效、淘汰等已使用过的医疗器械。

The import of expired, invalid, eliminated, or other used medical devices is prohibited.

出入境检验检疫机构依法对进口的医疗器械实施检验；检验不合格的，不得进口。

Entry-exit inspection and quarantine institutions shall inspect imported medical devices in accordance with the law; those that fail the inspection shall not be imported.

国务院药品监督管理部门应当及时向国家出入境检验检疫部门通报进口医疗器械的注册和备案情况。进口口岸所在地出入境检验检疫机构应当及时向所在地设区的市级人民政府负责药品监督管理的部门通报进口医疗器械的通关情况。

The drug regulatory authority of the State Council shall promptly notify the national entry-exit inspection and quarantine department of the registration and filing status of imported medical devices. The entry-exit inspection and quarantine institution at the port of import shall promptly notify the drug regulatory department of the people's government at the city divided into districts level where it is located of the customs clearance status of imported medical devices.

出口医疗器械的企业应当保证其出口的医疗器械符合进口国(地区)的要求。

Enterprises exporting medical devices shall ensure that the exported medical devices meet the requirements of the importing country (region).

医疗器械广告的内容应当真实合法，以经负责药品监督管理的部门注册或者备案的医疗器械说明书为准，不得含有虚假、夸大、误导性的内容。

The content of medical device advertisements shall be truthful and lawful, based on the medical device instructions that have been registered or filed with the drug regulatory department, and shall not contain false, exaggerated, or misleading content.

发布医疗器械广告，应当在发布前由省、自治区、直辖市人民政府确定的广告审查机关对广告内容进行审查，并取得医疗器械广告批准文号；未经审查，不得发布。

Before publishing a medical device advertisement, the advertisement review authority designated by the people's government of the province, autonomous region, or municipality directly under the Central Government shall review the content of the advertisement, and a medical device advertisement approval number shall be obtained; without review, the advertisement shall not be published.

省级以上人民政府药品监督管理部门责令暂停生产、进口、经营和使用的医疗器械，在暂停期间不得发布涉及该医疗器械的广告。

If the drug regulatory department at or above the provincial level orders the suspension of production, import, operation, and use of a medical device, advertisements involving that medical device shall not be published during the suspension period.

医疗器械广告的审查办法由国务院市场监督管理部门制定。

The measures for the review of medical device advertisements shall be formulated by the market regulatory authority of the State Council.

国家建立医疗器械不良事件监测制度，对医疗器械不良事件及时进行收集、分析、评价、控制。

The state establishes a medical device adverse event monitoring system to promptly collect, analyze, evaluate, and control medical device adverse events.

医疗器械注册人、备案人应当建立医疗器械不良事件监测体系，配备与其产品相适应的不良事件监测机构和人员，对其产品主动开展不良事件监测，并按照国务院药品监督管理部门的规定，向医疗器械不良事件监测技术机构报告调查、分析、评价、产品风险控制等情况。

Medical device registrants and filing persons shall establish a medical device adverse event monitoring system, equip themselves with adverse event monitoring institutions and personnel suitable for their products, proactively carry out adverse event monitoring for their products, and report the investigation, analysis, evaluation, and product risk control status to the medical device adverse event monitoring technical institution in accordance with the provisions of the drug regulatory authority of the State Council.

医疗器械生产经营企业、使用单位应当协助医疗器械注册人、备案人对所生产经营或者使用的医疗器械开展不良事件监测；发现医疗器械不良事件或者可疑不良事件，应当按照国务院药品监督管理部门的规定，向医疗器械不良事件监测技术机构报告。

Medical device production and operating enterprises and user units shall assist medical device registrants and filing persons in carrying out adverse event monitoring for the medical devices they produce, operate, or use; if they discover medical device adverse events or suspected adverse events, they shall report to the medical device adverse event monitoring technical institution in accordance with the provisions of the drug regulatory authority of the State Council.

其他单位和个人发现医疗器械不良事件或者可疑不良事件，有权向负责药品监督管理的部门或者医疗器械不良事件监测技术机构报告。

Other units and individuals who discover medical device adverse events or suspected adverse events have the right to report to the drug regulatory department or the medical device adverse event monitoring technical institution.

国务院药品监督管理部门应当加强医疗器械不良事件监测信息网络建设。

The drug regulatory authority of the State Council shall strengthen the construction of a medical device adverse event monitoring information network.

医疗器械不良事件监测技术机构应当加强医疗器械不良事件信息监测，主动收集不良事件信息；发现不良事件或者接到不良事件报告的，应当及时进行核实，必要时进行调查、分析、评估，向负责药品监督管理的部门和卫生主管部门报告并提出处理建议。

Medical device adverse event monitoring technical institutions shall strengthen the monitoring of medical device adverse event information and proactively collect adverse event information; upon discovering adverse events or receiving adverse event reports, they shall promptly verify, and if necessary, investigate, analyze, and evaluate, and report to the drug regulatory department and the health authority and provide handling suggestions.

医疗器械不良事件监测技术机构应当公布联系方式，方便医疗器械注册人、备案人、生产经营企业、使用单位等报告医疗器械不良事件。

Medical device adverse event monitoring technical institutions shall publish contact information to facilitate the reporting of medical device adverse events by medical device registrants, filing persons, production and operating enterprises, user units, etc.

负责药品监督管理的部门应当根据医疗器械不良事件评估结果及时采取发布警示信息以及责令暂停生产、进口、经营和使用等控制措施。

The drug regulatory department shall, based on the evaluation results of medical device adverse events, promptly take control measures such as issuing warning information and ordering the suspension of production, import, operation, and use.

省级以上人民政府药品监督管理部门应当会同同级卫生主管部门和相关部门组织对引起突发、群发的严重伤害或者死亡的医疗器械不良事件及时进行调查和处理，并组织对同类医疗器械加强监测。

The drug regulatory department at or above the provincial level shall, jointly with the health authority at the same level and relevant departments, organize the timely investigation and handling of medical device adverse events that cause sudden, mass, serious injury or death, and organize enhanced monitoring of similar medical devices.

负责药品监督管理的部门应当及时向同级卫生主管部门通报医疗器械使用单位的不良事件监测有关情况。

The drug regulatory department shall promptly notify the health authority at the same level of the adverse event monitoring status of medical device user units.

医疗器械注册人、备案人、生产经营企业、使用单位应当对医疗器械不良事件监测技术机构、负责药品监督管理的部门、卫生主管部门开展的医疗器械不良事件调查予以配合。

Medical device registrants, filing persons, production and operating enterprises, and user units shall cooperate with the medical device adverse event investigations carried out by medical device adverse event monitoring technical institutions, drug regulatory departments, and health authorities.

有下列情形之一的，医疗器械注册人、备案人应当主动开展已上市医疗器械再评价：

Medical device registrants and filing persons shall proactively carry out re-evaluation of marketed medical devices in any of the following circumstances:

(一)根据科学研究的发展，对医疗器械的安全、有效有认识上的改变；

(1) There is a change in understanding of the safety and effectiveness of the medical device based on the development of scientific research;

(二)医疗器械不良事件监测、评估结果表明医疗器械可能存在缺陷；

(2) The monitoring and evaluation of medical device adverse events indicate that the medical device may have defects;

(三)国务院药品监督管理部门规定的其他情形。

(3) Other circumstances stipulated by the drug regulatory authority of the State Council.

医疗器械注册人、备案人应当根据再评价结果，采取相应控制措施，对已上市医疗器械进行改进，并按照规定进行注册变更或者备案变更。再评价结果表明已上市医疗器械不能保证安全、有效的，医疗器械注册人、备案人应当主动申请注销医疗器械注册证或者取消备案；医疗器械注册人、备案人未申请注销医疗器械注册证或者取消备案的，由负责药品监督管理的部门注销医疗器械注册证或者取消备案。

Medical device registrants and filing persons shall, based on the re-evaluation results, take corresponding control measures, improve the marketed medical device, and carry out registration changes or filing changes in accordance with regulations. If the re-evaluation results show that the marketed medical device cannot ensure safety and effectiveness, the medical device registrant or filing person shall proactively apply for cancellation of the medical device registration certificate or cancellation of the filing; if the medical device registrant or filing person does not apply for cancellation of the medical device registration certificate or cancellation of the filing, the drug regulatory department shall cancel the medical device registration certificate or cancel the filing.

省级以上人民政府药品监督管理部门根据医疗器械不良事件监测、评估等情况，对已上市医疗器械开展再评价。再评价结果表明已上市医疗器械不能保证安全、有效的，应当注销医疗器械注册证或者取消备案。

The drug regulatory department at or above the provincial level shall, based on the monitoring and evaluation of medical device adverse events, carry out re-evaluation of marketed medical devices. If the re-evaluation results show that the marketed medical device cannot ensure safety and effectiveness, it shall cancel the medical device registration certificate or cancel the filing.

负责药品监督管理的部门应当向社会及时公布注销医疗器械注册证和取消备案情况。被注销医疗器械注册证或者取消备案的医疗器械不得继续生产、进口、经营、使用。

The drug regulatory department shall promptly publish to the public the cancellation of medical device registration certificates and the cancellation of filings. Medical devices whose registration certificates have been cancelled or filings have been cancelled shall not continue to be produced, imported, operated, or used.

医疗器械注册人、备案人发现生产的医疗器械不符合强制性标准、经注册或者备案的产品技术要求，或者存在其他缺陷的，应当立即停止生产，通知相关经营企业、使用单位和消费者停止经营和使用，召回已经上市销售的医疗器械，采取补救、销毁等措施，记录相关情况，发布相关信息，并将医疗器械召回和处理情况向负责药品监督管理的部门和卫生主管部门报告。

If a medical device registrant or filing person discovers that the medical device produced does not comply with mandatory standards, the registered or filed product technical requirements, or has other defects, it shall immediately stop production, notify relevant operating enterprises, user units, and consumers to stop operation and use, recall the marketed medical devices, take remedial and destruction measures, record the relevant situation, publish relevant information, and report the recall and handling of the medical device to the drug regulatory department and the health authority.

医疗器械受托生产企业、经营企业发现生产、经营的医疗器械存在前款规定情形的，应当立即停止生产、经营，通知医疗器械注册人、备案人，并记录停止生产、经营和通知情况。医疗器械注册人、备案人认为属于依照前款规定需要召回的医疗器械，应当立即召回。

If an entrusted medical device production enterprise or operating enterprise discovers that the medical device produced or operated has the circumstances specified in the preceding paragraph, it shall immediately stop production or operation, notify the medical device registrant or filing person, and record the cessation of production or operation and the notification. If the medical device registrant or filing person believes that the medical device needs to be recalled in accordance with the preceding paragraph, it shall immediately recall it.

医疗器械注册人、备案人、受托生产企业、经营企业未依照本条规定实施召回或者停止生产、经营的，负责药品监督管理的部门可以责令其召回或者停止生产、经营。

If a medical device registrant, filing person, entrusted production enterprise, or operating enterprise fails to implement the recall or stop production or operation in accordance with this Article, the drug regulatory department may order it to recall or stop production or operation.

国家建立职业化专业化检查员制度，加强对医疗器械的监督检查。

The state establishes a professional and specialized inspector system to strengthen the supervision and inspection of medical devices.

负责药品监督管理的部门应当对医疗器械的研制、生产、经营活动以及使用环节的医疗器械质量加强监督检查，并对下列事项进行重点监督检查：

The drug regulatory department shall strengthen the supervision and inspection of the development, production, and operation activities of medical devices and the quality of medical devices in the use link, and shall conduct key supervision and inspection on the following matters:

(一)是否按照经注册或者备案的产品技术要求组织生产；

(1) Whether production is organized in accordance with the registered or filed product technical requirements;

(二)质量管理体系是否保持有效运行；

(2) Whether the quality management system is maintained and effectively operated;

(三)生产经营条件是否持续符合法定要求。

(3) Whether the production and operation conditions continue to meet legal requirements.

必要时，负责药品监督管理的部门可以对为医疗器械研制、生产、经营、使用等活动提供产品或者服务的其他相关单位和个人进行延伸检查。

When necessary, the drug regulatory department may conduct extended inspections of other relevant units and individuals that provide products or services for activities such as the development, production, operation, and use of medical devices.

负责药品监督管理的部门在监督检查中有下列职权：

The drug regulatory department has the following powers during supervision and inspection:

(一)进入现场实施检查、抽取样品；

(1) Enter the site to conduct inspections and take samples;

(二)查阅、复制、查封、扣押有关合同、票据、账簿以及其他有关资料；

(2) Review, copy, seal, and seize relevant contracts, invoices, account books, and other relevant materials;

(三)查封、扣押不符合法定要求的医疗器械，违法使用的零配件、原材料以及用于违法生产经营医疗器械的工具、设备；

(3) Seal and seize medical devices that do not meet legal requirements, illegally used spare parts and raw materials, and tools and equipment used for illegal production and operation of medical devices;

(四)查封违反本条例规定从事医疗器械生产经营活动的场所。

(4) Seal premises where medical device production and operation activities are carried out in violation of this Regulation.

进行监督检查，应当出示执法证件，保守被检查单位的商业秘密。

When conducting supervision and inspection, law enforcement documents shall be presented, and the commercial secrets of the inspected unit shall be kept confidential.

有关单位和个人应当对监督检查予以配合，提供相关文件和资料，不得隐瞒、拒绝、阻挠。

Relevant units and individuals shall cooperate with the supervision and inspection, provide relevant documents and materials, and shall not conceal, refuse, or obstruct.

卫生主管部门应当对医疗机构的医疗器械使用行为加强监督检查。实施监督检查时，可以进入医疗机构，查阅、复制有关档案、记录以及其他有关资料。

The health authority shall strengthen the supervision and inspection of the use of medical devices by medical institutions. When conducting supervision and inspection, it may enter medical institutions, review and copy relevant files, records, and other relevant materials.

医疗器械生产经营过程中存在产品质量安全隐患，未及时采取措施消除的，负责药品监督管理的部门可以采取告诫、责任约谈、责令限期整改等措施。

If there are potential product quality safety hazards in the production and operation of medical devices and measures have not been taken to eliminate them in a timely manner, the drug regulatory department may take measures such as warnings, responsibility interviews, and ordering rectification within a time limit.

对人体造成伤害或者有证据证明可能危害人体健康的医疗器械，负责药品监督管理的部门可以采取责令暂停生产、进口、经营、使用的紧急控制措施，并发布安全警示信息。

For medical devices that cause harm to the human body or have evidence that they may endanger human health, the drug regulatory department may take emergency control measures such as ordering the suspension of production, import, operation, and use, and issue safety warning information.

负责药品监督管理的部门应当加强对医疗器械注册人、备案人、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。

The drug regulatory department shall strengthen the sampling and inspection of medical devices produced, operated, and used by medical device registrants, filing persons, production and operating enterprises, and user units. Sampling and inspection shall not charge inspection fees or any other fees, and the necessary expenses shall be included in the government budget at the same level. The drug regulatory department at or above the provincial level shall promptly publish medical device quality bulletins based on the sampling and inspection conclusions.

卫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 healthcompetent authority shall supervise and evaluate the use of large medical equipment; if anyviolation use or excessive examination and treatment related to large medical equipment is found, it shall be immediately corrected and dealt with according to law.

负责药品监督管理的部门未及时发现医疗器械安全系统性风险，未及时消除监督管理区域内医疗器械安全隐患的，本级人民政府或者上级人民政府负责药品监督管理的部门应当对其主要负责人进行约谈。

If the drug regulatory department fails to timely detect systemic risks in medical device safety or fails to timely eliminate medical device safety hazards within its supervisory area, the people's government at the same level or the drug regulatory department of the superior people's government shall interview its principal responsible person.

地方人民政府未履行医疗器械安全职责，未及时消除区域性重大医疗器械安全隐患的，上级人民政府或者上级人民政府负责药品监督管理的部门应当对其主要负责人进行约谈。

If a local people's government fails to fulfill its medical device safety responsibilities and fails to timely eliminate regional major medical device safety hazards, the superior people's government or the drug regulatory department of the superior people's government shall interview its principal responsible person.

被约谈的部门和地方人民政府应当立即采取措施，对医疗器械监督管理工作进行整改。

The interviewed department and local people's government shall immediately take measures to rectify the medical device supervision and administration work.

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。

The qualification accreditation of medical device inspection institutions shall be uniformly managed in accordance with relevant state regulations. Only inspection institutions accredited by the certification and accreditation regulatory department of the State Council jointly with the drug regulatory department of the State Council may conduct inspections on medical devices.

负责药品监督管理的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。

When the drug regulatory department needs to inspect medical devices in law enforcement, it shall entrust a qualified medical device inspection institution to conduct the inspection and pay the relevant fees.

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个工作日内向实施抽样检验的部门或者其上一级负责药品监督管理的部门提出复检申请，由受理复检申请的部门在复检机构名录中随机确定复检机构进行复检。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。复检机构与初检机构不得为同一机构；相关检验项目只有一家有资质的检验机构的，复检时应当变更承办部门或者人员。复检机构名录由国务院药品监督管理部门公布。

If a party disagrees with the inspection conclusion, it may, within 7 working days from receipt of the inspection conclusion, apply for a re-inspection to the department that conducted the sampling inspection or its superior drug regulatory department. The department accepting the re-inspection application shall randomly determine a re-inspection institution from the re-inspection institution list to conduct the re-inspection. The medical device inspection institution undertaking the re-inspection shall issue a re-inspection conclusion within the time limit prescribed by the drug regulatory department of the State Council. The re-inspection conclusion is the final inspection conclusion. The re-inspection institution and the initial inspection institution shall not be the same institution; if only one qualified inspection institution exists for the relevant inspection items, the undertaking department or personnel shall be changed during re-inspection. The re-inspection institution list shall be published by the drug regulatory department of the State Council.

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使用国务院药品监督管理部门批准的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，可以作为负责药品监督管理的部门认定医疗器械质量的依据。

For medical devices that may contain harmful substances or have unauthorized changes in design, raw materials, or production processes and pose safety hazards, if the inspection cannot be conducted according to the inspection items and methods specified in national or industry standards for medical devices, the medical device inspection institution may use supplementary inspection items and methods approved by the drug regulatory department of the State Council for inspection; the inspection conclusion obtained using supplementary inspection items and methods may serve as the basis for the drug regulatory department to determine the quality of the medical device.

市场监督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。

The market regulatory department shall, in accordance with the laws and administrative regulations on advertising management, supervise and inspect medical device advertisements and investigate and deal with illegal acts.

负责药品监督管理的部门应当通过国务院药品监督管理部门在线政务服务平台依法及时公布医疗器械许可、备案、抽查检验、违法行为查处等日常监督管理信息。但是，不得泄露当事人的商业秘密。

The drug regulatory department shall, through the online government service platform of the drug regulatory department of the State Council, timely publish daily supervision and administration information such as medical device licensing, filing, sampling inspection, and investigation and punishment of illegal acts according to law. However, it shall not disclose the business secrets of the parties involved.

负责药品监督管理的部门建立医疗器械注册人、备案人、生产经营企业、使用单位信用档案，对有不良信用记录的增加监督检查频次，依法加强失信惩戒。

The drug regulatory department shall establish credit files for medical device registrants, filers, production and operation enterprises, and user units, and increase the frequency of supervision and inspection for those with adverse credit records, and strengthen credit punishment according to law.

负责药品监督管理的部门等部门应当公布本单位的联系方式，接受咨询、投诉、举报。负责药品监督管理的部门等部门接到与医疗器械监督管理有关的咨询，应当及时答复；接到投诉、举报，应当及时核实、处理、答复。对咨询、投诉、举报情况及其答复、核实、处理情况，应当予以记录、保存。

The drug regulatory department and other departments shall publish their contact information to accept consultations, complaints, and reports. When the drug regulatory department and other departments receive consultations related to medical device supervision and administration, they shall respond in a timely manner; when they receive complaints or reports, they shall promptly verify, handle, and respond. The consultations, complaints, reports, and their responses, verifications, and handling shall be recorded and preserved.

有关医疗器械研制、生产、经营、使用行为的举报经调查属实的，负责药品监督管理的部门等部门对举报人应当给予奖励。有关部门应当为举报人保密。

If a report on the research and development, production, operation, or use of medical devices is verified to be true, the drug regulatory department and other departments shall reward the whistleblower. The relevant departments shall keep the whistleblower confidential.

国务院药品监督管理部门制定、调整、修改本条例规定的目录以及与医疗器械监督管理有关的规范，应当公开征求意见；采取听证会、论证会等形式，听取专家、医疗器械注册人、备案人、生产经营企业、使用单位、消费者、行业协会以及相关组织等方面的意见。

When the drug regulatory department of the State Council formulates, adjusts, or amends the catalogs specified in these Regulations and the norms related to medical device supervision and administration, it shall seek public opinions; it shall adopt forms such as hearings and demonstration meetings to listen to opinions from experts, medical device registrants, filers, production and operation enterprises, user units, consumers, industry associations, and related organizations.

有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的医疗器械和用于违法生产经营的工具、设备、原材料等物品；违法生产经营的医疗器械货值金额不足1万元的，并处5万元以上15万元以下罚款；货值金额1万元以上的，并处货值金额15倍以上30倍以下罚款；情节严重的，责令停产停业，10年内不受理相关责任人以及单位提出的医疗器械许可申请，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，终身禁止其从事医疗器械生产经营活动：

In any of the following circumstances, the drug regulatory department shall confiscate the illegal income, the illegally produced or operated medical devices, and the tools, equipment, raw materials, and other articles used for illegal production or operation; if the value of the illegally produced or operated medical devices is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed; if the value is 10,000 yuan or more, a fine of not less than 15 times but not more than 30 times the value shall be imposed; if the circumstances are serious, the production or operation shall be ordered to stop, and the relevant responsible persons and units shall not be accepted for medical device licensing applications within 10 years; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and they shall be permanently prohibited from engaging in medical device production or operation activities:

(一)生产、经营未取得医疗器械注册证的第二类、第三类医疗器械；

(1) Producing or operating Class II or Class III medical devices without obtaining a medical device registration certificate;

(二)未经许可从事第二类、第三类医疗器械生产活动；

(2) Engaging in the production of Class II or Class III medical devices without a license;

(三)未经许可从事第三类医疗器械经营活动。

(3) Engaging in the operation of Class III medical devices without a license.

有前款第一项情形、情节严重的，由原发证部门吊销医疗器械生产许可证或者医疗器械经营许可证。

If the circumstances in the preceding paragraph (1) are serious, the original issuing department shall revoke the medical device production license or medical device operation license.

未经许可擅自配置使用大型医用设备的，由县级以上人民政府卫生主管部门责令停止使用，给予警告，没收违法所得；违法所得不足1万元的，并处5万元以上10万元以下罚款；违法所得1万元以上的，并处违法所得10倍以上30倍以下罚款；情节严重的，5年内不受理相关责任人以及单位提出的大型医用设备配置许可申请，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分。

If large medical equipment is configured and used without a license, the healthcompetent authority of the people's government at or above the county level shall order the cessation of use, issue a warning, and confiscate illegal income; if the illegal income is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the illegal income is 10,000 yuan or more, a fine of not less than 10 times but not more than 30 times the illegal income shall be imposed; if the circumstances are serious, the relevant responsible persons and units shall not be accepted for large medical equipment configuration license applications within 5 years; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and administrative sanctions shall be imposed according to law.

在申请医疗器械行政许可时提供虚假资料或者采取其他欺骗手段的，不予行政许可，已经取得行政许可的，由作出行政许可决定的部门撤销行政许可，没收违法所得、违法生产经营使用的医疗器械，10年内不受理相关责任人以及单位提出的医疗器械许可申请；违法生产经营使用的医疗器械货值金额不足1万元的，并处5万元以上15万元以下罚款；货值金额1万元以上的，并处货值金额15倍以上30倍以下罚款；情节严重的，责令停产停业，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，终身禁止其从事医疗器械生产经营活动。

If false materials are provided or other deceptive means are used in applying for medical device administrative licensing, the administrative licensing shall not be granted; if administrative licensing has already been granted, the department that made the licensing decision shall revoke the administrative licensing, confiscate illegal income, and the illegally produced, operated, or used medical devices; the relevant responsible persons and units shall not be accepted for medical device licensing applications within 10 years; if the value of the illegally produced, operated, or used medical devices is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed; if the value is 10,000 yuan or more, a fine of not less than 15 times but not more than 30 times the value shall be imposed; if the circumstances are serious, production or operation shall be ordered to stop; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and they shall be permanently prohibited from engaging in medical device production or operation activities.

伪造、变造、买卖、出租、出借相关医疗器械许可证件的，由原发证部门予以收缴或者吊销，没收违法所得；违法所得不足1万元的，并处5万元以上10万元以下罚款；违法所得1万元以上的，并处违法所得10倍以上20倍以下罚款；构成违反治安管理行为的，由公安机关依法予以治安管理处罚。

If relevant medical device licenses are forged, altered, bought, sold, rented, or lent, the original issuing department shall confiscate or revoke them, and confiscate illegal income; if the illegal income is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the illegal income is 10,000 yuan or more, a fine of not less than 10 times but not more than 20 times the illegal income shall be imposed; if the act constitutes a violation of public security administration, the public security organ shall impose public security administration penalties according to law.

有下列情形之一的，由负责药品监督管理的部门向社会公告单位和产品名称，责令限期改正；逾期不改正的，没收违法所得、违法生产经营的医疗器械；违法生产经营的医疗器械货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：

In any of the following circumstances, the drug regulatory department shall publicly announce the unit and product name, and order correction within a specified period; if correction is not made within the period, illegal income and illegally produced or operated medical devices shall be confiscated; if the value of the illegally produced or operated medical devices is less than 10,000 yuan, a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed; if the value is 10,000 yuan or more, a fine of not less than 5 times but not more than 20 times the value shall be imposed; if the circumstances are serious, for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 2 times the income obtained shall be imposed, and they shall be prohibited from engaging in medical device production or operation activities for 5 years:

(一)生产、经营未经备案的第一类医疗器械；

(1) Producing or operating Class I medical devices that have not been filed;

(二)未经备案从事第一类医疗器械生产；

(2) Engaging in the production of Class I medical devices without filing;

(三)经营第二类医疗器械，应当备案但未备案；

(3) Operating Class II medical devices that should have been filed but were not;

(四)已经备案的资料不符合要求。

(4) The filed materials do not meet the requirements.

备案时提供虚假资料的，由负责药品监督管理的部门向社会公告备案单位和产品名称，没收违法所得、违法生产经营的医疗器械；违法生产经营的医疗器械货值金额不足1万元的，并处2万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，10年内禁止其从事医疗器械生产经营活动。

If false materials are provided during filing, the drug regulatory department shall publicly announce the filing unit and product name, confiscate illegal income and illegally produced or operated medical devices; if the value of the illegally produced or operated medical devices is less than 10,000 yuan, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the value is 10,000 yuan or more, a fine of not less than 5 times but not more than 20 times the value shall be imposed; if the circumstances are serious, production or operation shall be ordered to stop; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and they shall be prohibited from engaging in medical device production or operation activities for 10 years.

有下列情形之一的，由负责药品监督管理的部门责令改正，没收违法生产经营使用的医疗器械；违法生产经营使用的医疗器械货值金额不足1万元的，并处2万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，10年内禁止其从事医疗器械生产经营活动：

In any of the following circumstances, the drug regulatory department shall order correction, confiscate illegally produced, operated, or used medical devices; if the value of the illegally produced, operated, or used medical devices is less than 10,000 yuan, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the value is 10,000 yuan or more, a fine of not less than 5 times but not more than 20 times the value shall be imposed; if the circumstances are serious, production or operation shall be ordered to stop, until the original issuing department revokes the medical device registration certificate, medical device production license, or medical device operation license; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and they shall be prohibited from engaging in medical device production or operation activities for 10 years:

(一)生产、经营、使用不符合强制性标准或者不符合经注册或者备案的产品技术要求的医疗器械；

(1) Producing, operating, or using medical devices that do not comply with mandatory standards or the product technical requirements specified in the registration or filing;

(二)未按照经注册或者备案的产品技术要求组织生产，或者未依照本条例规定建立质量管理体系并保持有效运行，影响产品安全、有效；

(2) Failing to organize production according to the registered or filed product technical requirements, or failing to establish a quality management system and maintain its effective operation in accordance with these Regulations, affecting product safety and effectiveness;

(三)经营、使用无合格证明文件、过期、失效、淘汰的医疗器械，或者使用未依法注册的医疗器械；

(3) Operating or using medical devices without conformity certificates, expired,invalid, or obsolete medical devices, or using medical devices that are not legally registered;

(四)在负责药品监督管理的部门责令召回后仍拒不召回，或者在负责药品监督管理的部门责令停止或者暂停生产、进口、经营后，仍拒不停止生产、进口、经营医疗器械；

(4) Refusing to recall after being ordered by the drug regulatory department, or refusing to stop production, import, or operation after being ordered by the drug regulatory department to stop or suspend production, import, or operation of medical devices;

(五)委托不具备本条例规定条件的企业生产医疗器械，或者未对受托生产企业的生产行为进行管理；

(5) Entrusting an enterprise that does not meet the conditions specified in these Regulations to produce medical devices, or failing to manage the production activities of the entrusted production enterprise;

(六)进口过期、失效、淘汰等已使用过的医疗器械。

(6) Importing used medical devices such as expired,invalid, or obsolete ones.

医疗器械经营企业、使用单位履行了本条例规定的进货查验等义务，有充分证据证明其不知道所经营、使用的医疗器械为本条例第八十一条第一款第一项、第八十四条第一项、第八十六条第一项和第三项规定情形的医疗器械，并能如实说明其进货来源的，收缴其经营、使用的不符合法定要求的医疗器械，可以免除行政处罚。

If a medical device operation enterprise or user unit has fulfilled the obligations ofincoming inspection and other obligations specified in these Regulations, has sufficient evidence to prove that it did not know that the medical devices it operated or used were those specified in Article 81(1), Article 84(1), Article 86(1) and (3) of these Regulations, and can truthfully explain the source of purchase, the medical devices that do not meet the legal requirements shall be confiscated, and administrative penalties may be exempted.

有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：

In any of the following circumstances, the drug regulatory department shall order correction and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan; if correction is refused, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, production or operation shall be ordered to stop, until the original issuing department revokes the medical device production license or medical device operation license; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 2 times the income obtained shall be imposed, and they shall be prohibited from engaging in medical device production or operation activities for 5 years:

(一)生产条件发生变化、不再符合医疗器械质量管理体系要求，未依照本条例规定整改、停止生产、报告；

(1) When production conditions change and no longer meet the requirements of the medical device quality management system, failing to rectify, stop production, or report in accordance with these Regulations;

(二)生产、经营说明书、标签不符合本条例规定的医疗器械；

(2) Producing or operating medical devices whose instructions or labels do not comply with these Regulations;

(三)未按照医疗器械说明书和标签标示要求运输、贮存医疗器械；

(3) Failing to transport or store medical devices in accordance with the requirements of the medical device instructions and label markings;

(四)转让过期、失效、淘汰或者检验不合格的在用医疗器械。

(4) Transferring used medical devices that are expired,invalid, obsolete, or have failed inspection.

有下列情形之一的，由负责药品监督管理的部门和卫生主管部门依据各自职责责令改正，给予警告；拒不改正的，处1万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械注册证、医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员处1万元以上3万元以下罚款：

In any of the following circumstances, the drug regulatory department and the healthcompetent authority shall, within their respective responsibilities, order correction and issue a warning; if correction is refused, a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, production or operation shall be ordered to stop, until the original issuing department revokes the medical device registration certificate, medical device production license, or medical device operation license; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed:

(一)未按照要求提交质量管理体系自查报告；

(1) Failing to submit a quality management system self-inspection report as required;

(二)从不具备合法资质的供货者购进医疗器械；

(2) Purchasing medical devices from suppliers without legal qualifications;

(三)医疗器械经营企业、使用单位未依照本条例规定建立并执行医疗器械进货查验记录制度；

(3) A medical device operation enterprise or user unit failing to establish and implement a medical device purchase inspection record system in accordance with these Regulations;

(四)从事第二类、第三类医疗器械批发业务以及第三类医疗器械零售业务的经营企业未依照本条例规定建立并执行销售记录制度；

(4) An operation enterprise engaged in wholesale of Class II or Class III medical devices or retail of Class III medical devices failing to establish and implement a sales record system in accordance with these Regulations;

(五)医疗器械注册人、备案人、生产经营企业、使用单位未依照本条例规定开展医疗器械不良事件监测，未按照要求报告不良事件，或者对医疗器械不良事件监测技术机构、负责药品监督管理的部门、卫生主管部门开展的不良事件调查不予配合；

(5) A medical device registrant, filer, production or operation enterprise, or user unit failing to conduct medical device adverse event monitoring in accordance with these Regulations, failing to report adverse events as required, or failing to cooperate with adverse event investigations conducted by medical device adverse event monitoring technical institutions, the drug regulatory department, or the healthcompetent authority;

(六)医疗器械注册人、备案人未按照规定制定上市后研究和风险管控计划并保证有效实施；

(6) A medical device registrant or filer failing to formulate a post-market study and risk management plan and ensure its effective implementation as required;

(七)医疗器械注册人、备案人未按照规定建立并执行产品追溯制度；

(7) A medical device registrant or filer failing to establish and implement a product traceability system as required;

(八)医疗器械注册人、备案人、经营企业从事医疗器械网络销售未按照规定告知负责药品监督管理的部门；

(8) A medical device registrant, filer, or operation enterprise engaging in online sales of medical devices without notifying the drug regulatory department as required;

(九)对需要定期检查、检验、校准、保养、维护的医疗器械，医疗器械使用单位未按照产品说明书要求进行检查、检验、校准、保养、维护并予以记录，及时进行分析、评估，确保医疗器械处于良好状态；

(9) For medical devices that require regular inspection, testing, calibration, maintenance, or servicing, the medical device user unit failing to conduct inspection, testing, calibration, maintenance, or servicing in accordance with the product instructions and record them, and failing to timely analyze and evaluate to ensure the medical device is in good condition;

(十)医疗器械使用单位未妥善保存购入第三类医疗器械的原始资料。

(10) A medical device user unit failing to properly preserve the original materials of purchased Class III medical devices.

有下列情形之一的，由县级以上人民政府卫生主管部门责令改正，给予警告；拒不改正的，处5万元以上10万元以下罚款；情节严重的，处10万元以上30万元以下罚款，责令暂停相关医疗器械使用活动，直至由原发证部门吊销执业许可证，依法责令相关责任人员暂停6个月以上1年以下执业活动，直至由原发证部门吊销相关人员执业证书，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分：

In any of the following circumstances, the healthcompetent authority of the people's government at or above the county level shall order correction and issue a warning; if correction is refused, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; if the circumstances are serious, a fine of not less than 100,000 yuan but not more than 300,000 yuan shall be imposed, the relevant medical device use activities shall be suspended, until the original issuing department revokes the practice license, and the relevant responsible persons shall be ordered to suspend practice for not less than 6 months but not more than 1 year according to law, until the original issuing department revokes the practice certificate of the relevant personnel; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and administrative sanctions shall be imposed according to law:

(一)对重复使用的医疗器械，医疗器械使用单位未按照消毒和管理的规定进行处理；

(1) For reusable medical devices, the medical device user unit fails to handle them in accordance with disinfection and management regulations;

(二)医疗器械使用单位重复使用一次性使用的医疗器械，或者未按照规定销毁使用过的一次性使用的医疗器械；

(2) A medical device user unit reuses single-use medical devices, or fails to destroy used single-use medical devices as required;

(三)医疗器械使用单位未按照规定将大型医疗器械以及植入和介入类医疗器械的信息记载到病历等相关记录中；

(3) A medical device user unit fails to record information on large medical devices and implantable or interventional medical devices in medical records and other relevant records as required;

(四)医疗器械使用单位发现使用的医疗器械存在安全隐患未立即停止使用、通知检修，或者继续使用经检修仍不能达到使用安全标准的医疗器械；

(4) A medical device user unit, upon discovering that the medical device in use has safety hazards, fails to immediately stop use, notify for repair, or continues to use a medical device that still cannot meet safety standards after repair;

(五)医疗器械使用单位违规使用大型医用设备，不能保障医疗质量安全。

(5) A medical device user unit uses large medical equipment in violation of regulations, failing to ensure medical quality and safety.

违反进出口商品检验相关法律、行政法规进口医疗器械的，由出入境检验检疫机构依法处理。

If medical devices are imported in violation of laws and administrative regulations on import and export commodity inspection, the entry-exit inspection and quarantine authority shall handle the matter according to law.

为医疗器械网络交易提供服务的电子商务平台经营者违反本条例规定，未履行对入网医疗器械经营者进行实名登记，审查许可、注册、备案情况，制止并报告违法行为，停止提供网络交易平台服务等管理义务的，由负责药品监督管理的部门依照《中华人民共和国电子商务法》的规定给予处罚。

If an e-commerce platform operator providing services for medical device online transactions fails to fulfill its management obligations such as conducting real-name registration of medical device operators on the platform, reviewing licensing, registration, and filing status, stopping and reporting illegal acts, and ceasing to provide online transaction platform services in violation of these Regulations, the drug regulatory department shall impose penalties in accordance with the E-Commerce Law of the People's Republic of China.

未进行医疗器械临床试验机构备案开展临床试验的，由负责药品监督管理的部门责令停止临床试验并改正；拒不改正的，该临床试验数据不得用于产品注册、备案，处5万元以上10万元以下罚款，并向社会公告；造成严重后果的，5年内禁止其开展相关专业医疗器械临床试验，并处10万元以上30万元以下罚款，由卫生主管部门对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分。

If a clinical trial is conducted without filing the medical device clinical trial institution, the drug regulatory department shall order the cessation of the clinical trial and correction; if correction is refused, the clinical trial data shall not be used for product registration or filing, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed, and a public announcement shall be made; if serious consequences are caused, the institution shall be prohibited from conducting relevant professional medical device clinical trials for 5 years, and a fine of not less than 100,000 yuan but not more than 300,000 yuan shall be imposed; the healthcompetent authority shall confiscate the income obtained from the unit during the period of the illegal act from the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, and impose a fine of not less than 30% but not more than 3 times the income obtained, and impose administrative sanctions according to law.

临床试验申办者开展临床试验未经备案的，由负责药品监督管理的部门责令停止临床试验，对临床试验申办者处5万元以上10万元以下罚款，并向社会公告；造成严重后果的，处10万元以上30万元以下罚款。该临床试验数据不得用于产品注册、备案，5年内不受理相关责任人以及单位提出的医疗器械注册申请。

If a clinical trial sponsor conducts a clinical trial without filing, the drug regulatory department shall order the cessation of the clinical trial, impose a fine of not less than 50,000 yuan but not more than 100,000 yuan on the clinical trial sponsor, and make a public announcement; if serious consequences are caused, a fine of not less than 100,000 yuan but not more than 300,000 yuan shall be imposed. The clinical trial data shall not be used for product registration or filing, and the relevant responsible persons and units shall not be accepted for medical device registration applications within 5 years.

临床试验申办者未经批准开展对人体具有较高风险的第三类医疗器械临床试验的，由负责药品监督管理的部门责令立即停止临床试验，对临床试验申办者处10万元以上30万元以下罚款，并向社会公告；造成严重后果的，处30万元以上100万元以下罚款。该临床试验数据不得用于产品注册，10年内不受理相关责任人以及单位提出的医疗器械临床试验和注册申请，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款。

If a clinical trial sponsor conducts a clinical trial of a Class III medical device with high risk to the human body without approval, the drug regulatory department shall order the immediate cessation of the clinical trial, impose a fine of not less than 100,000 yuan but not more than 300,000 yuan on the clinical trial sponsor, and make a public announcement; if serious consequences are caused, a fine of not less than 300,000 yuan but not more than 1,000,000 yuan shall be imposed. The clinical trial data shall not be used for product registration, and the relevant responsible persons and units shall not be accepted for medical device clinical trial and registration applications within 10 years; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed.

医疗器械临床试验机构开展医疗器械临床试验未遵守临床试验质量管理规范的，由负责药品监督管理的部门责令改正或者立即停止临床试验，处5万元以上10万元以下罚款；造成严重后果的，5年内禁止其开展相关专业医疗器械临床试验，由卫生主管部门对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分。

If a medical device clinical trial institution conducts a clinical trial without complying with the clinical trial quality management standards, the drug regulatory department shall order correction or immediate cessation of the clinical trial, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if serious consequences are caused, the institution shall be prohibited from conducting relevant professional medical device clinical trials for 5 years; the healthcompetent authority shall confiscate the income obtained from the unit during the period of the illegal act from the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, and impose a fine of not less than 30% but not more than 3 times the income obtained, and impose administrative sanctions according to law.

医疗器械临床试验机构出具虚假报告的，由负责药品监督管理的部门处10万元以上30万元以下罚款；有违法所得的，没收违法所得；10年内禁止其开展相关专业医疗器械临床试验；由卫生主管部门对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分。

If a medical device clinical trial institution issues a false report, the drug regulatory department shall impose a fine of not less than 100,000 yuan but not more than 300,000 yuan; if there is illegal income, the illegal income shall be confiscated; the institution shall be prohibited from conducting relevant professional medical device clinical trials for 10 years; the healthcompetent authority shall confiscate the income obtained from the unit during the period of the illegal act from the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, and impose a fine of not less than 30% but not more than 3 times the income obtained, and impose administrative sanctions according to law.

医疗器械检验机构出具虚假检验报告的，由授予其资质的主管部门撤销检验资质，10年内不受理相关责任人以及单位提出的资质认定申请，并处10万元以上30万元以下罚款；有违法所得的，没收违法所得；对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上3倍以下罚款，依法给予处分；受到开除处分的，10年内禁止其从事医疗器械检验工作。

If a medical device inspection institution issues a false inspection report, the competent department that granted its qualification shall revoke the inspection qualification, and the relevant responsible persons and units shall not be accepted for qualification accreditation applications within 10 years, and a fine of not less than 100,000 yuan but not more than 300,000 yuan shall be imposed; if there is illegal income, the illegal income shall be confiscated; for the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit, the income obtained from the unit during the period of the illegal act shall be confiscated, and a fine of not less than 30% but not more than 3 times the income obtained shall be imposed, and administrative sanctions shall be imposed according to law; if dismissed, they shall be prohibited from engaging in medical device inspection work for 10 years.

违反本条例有关医疗器械广告管理规定的，依照《中华人民共和国广告法》的规定给予处罚。

If the provisions of these Regulations on medical device advertising management are violated, penalties shall be imposed in accordance with the Advertising Law of the People's Republic of China.

境外医疗器械注册人、备案人指定的我国境内企业法人未依照本条例规定履行相关义务的，由省、自治区、直辖市人民政府药品监督管理部门责令改正，给予警告，并处5万元以上10万元以下罚款；情节严重的，处10万元以上50万元以下罚款，5年内禁止其法定代表人、主要负责人、直接负责的主管人员和其他责任人员从事医疗器械生产经营活动。

If the domestic enterprise legal person designated by an overseas medical device registrant or filer fails to fulfill the relevant obligations in accordance with these Regulations, the drug regulatory department of the provincial, autonomous region, or municipality directly under the Central Government shall order correction, issue a warning, and impose a fine of not less than 50,000 yuan but not more than 100,000 yuan; if the circumstances are serious, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed, and its legal representative, principal responsible person, directly responsible supervisor, and other responsible persons shall be prohibited from engaging in medical device production or operation activities for 5 years.

境外医疗器械注册人、备案人拒不履行依据本条例作出的行政处罚决定的，10年内禁止其医疗器械进口。

If an overseas medical device registrant or filer refuses to comply with the administrative penalty decision made in accordance with these Regulations, its medical devices shall be prohibited from importation for 10 years.

医疗器械研制、生产、经营单位和检验机构违反本条例规定使用禁止从事医疗器械生产经营活动、检验工作的人员的，由负责药品监督管理的部门责令改正，给予警告；拒不改正的，责令停产停业直至吊销许可证件。

If a medical device research and development, production, or operation unit or inspection institution employs personnel who are prohibited from engaging in medical device production, operation, or inspection activities in violation of these Regulations, the drug regulatory department shall order correction and issue a warning; if correction is refused, production or operation shall be ordered to stop until the license is revoked.

医疗器械技术审评机构、医疗器械不良事件监测技术机构未依照本条例规定履行职责，致使审评、监测工作出现重大失误的，由负责药品监督管理的部门责令改正，通报批评，给予警告；造成严重后果的，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，依法给予处分。

If a medical device technical review institution or medical device adverse event monitoring technical institution fails to perform its duties in accordance with these Regulations, resulting in major errors in review or monitoring, the drug regulatory department shall order correction, circulate a notice of criticism, and issue a warning; if serious consequences are caused, administrative sanctions shall be imposed on the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons of the illegal unit according to law.

负责药品监督管理的部门或者其他有关部门工作人员违反本条例规定，滥用职权、玩忽职守、徇私舞弊的，依法给予处分。

If a staff member of the drug regulatory department or other relevant department abuses power, neglects duty, or engages in malpractice for personal gain in violation of these Regulations, administrative sanctions shall be imposed according to law.

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。

If a violation of these Regulations constitutes a crime, criminal liability shall be pursued according to law; if personal injury, property damage, or other damage is caused, compensation liability shall be borne according to law.

本条例下列用语的含义：

The meanings of the following terms in these Regulations:

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：

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items, including the required computer software, used directly or indirectly on the human body; their effectiveness is mainly obtained through physical means, not through pharmacological, immunological, or metabolic means, or although these means are involved, they only play a supporting role; their purposes are:

(一)疾病的诊断、预防、监护、治疗或者缓解；

(1) Diagnosis, prevention, monitoring, treatment, or alleviation of diseases;

(二)损伤的诊断、监护、治疗、缓解或者功能补偿；

(2) Diagnosis, monitoring, treatment, alleviation, or functional compensation of injuries;

(三)生理结构或者生理过程的检验、替代、调节或者支持；

(3) Examination, replacement, regulation, or support of physiological structures or physiological processes;

(四)生命的支持或者维持；

(4) Life support or maintenance;

(五)妊娠控制；

(5) Pregnancy control;

(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。

(6) Providing information for medical or diagnostic purposes by examining samples from the human body.

医疗器械注册人、备案人，是指取得医疗器械注册证或者办理医疗器械备案的企业或者研制机构。

Medical device registrants and filers refer to enterprises or research institutions that have obtained medical device registration certificates or completed medical device filing.

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，包括医疗机构、血站、单采血浆站、康复辅助器具适配机构等。

Medical device user units refer to institutions that use medical devices to provide medical and other technical services to others, including medical institutions, blood stations, plasma collection stations, and rehabilitation assistive device adaptation institutions.

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 equipment refers to large medical devices that are complex in use technology, require large capital investment, have high operating costs, have a significant impact on medical expenses, and are included in catalog management.

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。

Fees may be charged for medical device product registration. The specific charging items and standards shall be determined by the finance and price authorities of the State Council in accordance with relevant state regulations.

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，由国务院药品监督管理部门会同国务院卫生主管部门制定。

The management measures for medical devices developed by medical and health institutions to respond to public health emergencies shall be formulated by the drug regulatory department of the State Council jointly with the healthcompetent authority of the State Council.

从事非营利的避孕医疗器械的存储、调拨和供应，应当遵守国务院卫生主管部门会同国务院药品监督管理部门制定的管理办法。

The storage, allocation, and supply of non-profit contraceptive medical devices shall comply with the management measures formulated by the healthcompetent authority of the State Council jointly with the drug regulatory department of the State Council.

中医医疗器械的技术指导原则，由国务院药品监督管理部门会同国务院中医药管理部门制定。

The technical guidance principles for traditional Chinese medicine medical devices shall be formulated by the drug regulatory department of the State Council jointly with the traditional Chinese medicine administration department of the State Council.

军队医疗器械使用的监督管理，依照本条例和军队有关规定执行。

The supervision and administration of the use of medical devices by the military shall be implemented in accordance with these Regulations and the relevant military provisions.

本条例自2021年6月1日起施行。

These Regulations shall come into effect on June 1, 2021.