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1、医疗器械临床使用管理方法Measures for the Administration of the Clinical Use of Medical Devices【中英文对照版】发布部门：国家卫生健康委员会发文字号：中华人民共和国国家卫生健康委员会令第8号发布日期：实施日期：效力级别：部门规章法规类别：卫生综合规定医疗器械药品药材进出口Issuing Authority : National Health CommissionDocument Number : Order N. 8 of the National Health Commission of the Peoples Republ
2、ic ofChinaDate Issued ： 01-12-2021Effective Date ： 03-01-2021Level of Authority : Departmental Rules中华人民共和国国家卫生健 康委员会令Area of Law : General Provisions on Health and Sanitation Import and Export of Medical Devices, Drugs, and Medicine MaterialsOrder of the National Health Commission of the Peoples Re
3、public of China(N0. 8)医疗器械临床使用管理办 法已经2020年12月4日 第2次委务会议审议通过， 现予公布，自2021年3月 1日起施行。主任马晓伟（第8号）The Measures for the Administration of the Clinical Use of Medical Devices, as deliberated and adopted at the second executive meeting on December 4, 2020, are hereby issued, and shall come into force on March
4、 1,2021.Director: Ma XiaoweiJanuary 12, 2021January 12, 20212021年1月12日医疗器械临床使用管理方法医疗器械临床使用管理方法Measures for the Administration of the Clinical Use ofMedical Devices第二十五条医疗机构 应当开展医疗器械临床使用 平安管理，对生命支持类、 急救类、植入类、辐射类、 灭菌类和大型医疗器械实行 使用平安监测与报告制度。第二十六条医疗机构匹配的生命支持医疗器械和 相关重要医疗器械故障紧急 替代流程，配备必要的替代 设备设施，并对急救的医疗 器械
5、实行专管专用，保证临 床急救工作正常开展。的医疗器械存在平安隐患 的，医疗机构应当立即停止 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 检修仍不能到达使用平安标 准的医疗器械，不得继续使第二十八条医疗机构 应当严格执行医院感染管理 有关法律法规的规定，使用 符合国家规定的消毒器械和 一次性使用的医疗器械。按A medical institution shall conduct safety management of the clinical use of medical devices, and implement a monitoring and repo
6、rting system for the safe use of life support, first aid, implantable, radiation, sterilization and large medical devices.Article 25 A medical institution shall formulate emergency replacement procedures for the failure of 应当制订与其规模、 功能相life-support medical devices and relevant important medical devi
7、ces in accordance with its scale and functions, equip itself with necessary alternative equipment and facilities, and conduct special management of first-aid medical devices and specify their use for special purpose, so as to ensure the normal operation of clinical first-aid work.第二十七条发现使用Once any m
8、edical device in use is found to have potential safety hazards, the medical institution shall immediately cease its use and notify the registrant or recordation entity of the medical device or any other institution responsible for product quality of conducting an overhaul; the medical device that fa
9、ils to meet the safety standards after being overhauled shall not continue to be used.用。Article 26 A medical institution shall strictly implement the provisions of relevant laws and regulations on hospital infection management, and use disinfection devices and disposable medical devices that comply
10、with the provisions issued by the state. Medical devices that may be reused according to the10relevant provisions shall be cleaned, disinfected or sterilized in strict accordance with applicable provisions, and be subject to effectiveness monitoring; disposable medical devices shall not be reused, a
11、nd used disposable medical devices shall be destroyed and recorded in accordance with applicable provisions issued by the state.规定可以重复使用的医疗器 械，应当严格按照规定清 洗、消毒或者灭菌，并进行 效果监测；一次性使用的医 疗器械不得重复使用，使用 过的应当按照国家有关规定 销毁并记录。A medical institution shall, before using any sterile 使用无菌医疗器械前，应当medical device, conduct
12、 a routine inspection of the package in direct contact with the medical device and the service life thereof, and conscientiously check the specifications, model, and effective date of disinfection or sterilization, among others, of the medical device. A medical device shall not be used if its packag
13、e is destroyed, its label is not clear, its service life has expired or its safe use may be affected.Article 27 During the clinical use of a large-scale medical devices or an implantable or interventional medical device, the name of the medical device, key technical parameters and other information
14、as well as necessary information closely related to the quality and safety of its use shall be recorded in relevant records such as medical records.Article 28 A medical institution shall evaluate the clinical use of medical devices as required, with the focus on strengthening the evaluation of the c
15、linical effectiveness, reliability and usability of medical devices.对直接接触医疗器械的包装 及其有效期进行常规检查， 认真核对其规格、型号、消 毒或者灭菌有效日期等。包 装破损、标示不清、超过有 效期或者可能影响使用平安 的，不得使用。第二十九条临床使用 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 平安密切相关的必要信息记 载到病历等相关记录中。第三十条医疗机构应 当按照规定开展医疗器械临 床使用评价工作，重点加强 医疗器械的临床实效性、可 靠性和可用性评价。Cha
16、pter IV Safeguards and Maintenance Management 第四章 保障维护管理11Article 29 The safeguards and maintenance management of medical devices shall focus on testing and preventive maintenance. The appropriateness of the performance of medical devices and the safety of their use shall be verified through perform
17、ance testing and safety monitoring; the service life of medical devices will be prolonged and malfunctions will be prevented through preventive maintenance such as replacement of components and cleaning.Article 30 A medical institution shall monitor the operating status of its medical devices, track
18、 and record the entire process of maintenance and repair, and analyze and evaluate the overall maintenance of its medical devices on a regular basis.Article 31 A medical institution shall comply with the relevant national standards, procedures, and technical guidelines for medical devices, ensure th
19、at the power, temperature and humidity, radiation protection, magnetic field shielding, illumination brightness in the system environment and other factors are commensurate with its medical devices, and test, evaluate and maintain the environment where its medical devices are used.Article 32 A medic
20、al institution shall have storage places and conditions commensurate with the varieties第三十一条医疗器械 保障维护管理应当重点进行 检测和预防性维护。通过开 展性能检测和平安监测，验 证医疗器械性能的适当性和 使用的平安性；通过开展部 件更换、清洁等预防性维 护，延长医疗器械使用寿命 并预防故障发生。第三十一条医疗器械 保障维护管理应当重点进行 检测和预防性维护。通过开 展性能检测和平安监测，验 证医疗器械性能的适当性和 使用的平安性；通过开展部 件更换、清洁等预防性维 护，延长医疗器械使用寿命 并预防故障
21、发生。第三十二条医疗机构 应当监测医疗器械的运行状 态，对维护与维修的全部过 程进行跟踪记录，定期分析 评价医疗器械整体维护情 况。第三十三条医疗机构 应当遵照国家有关医疗器械 标准、规程、技术指南等， 确保系统环境电源、温湿 度、辐射防护、磁场屏蔽、 光照亮度等因素与医疗器械 相适应，定期对医疗器械使 用环境进行测试、评估和维 护。第三十四条医疗机构 应当具备与医疗器械品种、12and quantities of its medical devices. Where there are special requirements for environmental conditions suc
22、h as temperature and humidity, corresponding measures shall be taken to ensure the safety and effectiveness of medical devices.数量相适应的贮存场所和条 件。对温度、湿度等环境条 件有特殊要求的，应当采取 相应措施，保证医疗器械安 全、有效。Article 35 A medical institution shall truthfully record information on the safeguards for medical devices and depos
23、it such information in the information files of medical devices. The files shall be retained for not less第三十五条医疗机构 应当真实记录医疗器械保障 情况并存入医疗器械信息档 案，档案保存期限不得少于than five years after the expiration of the prescribed service life of its medical devices.医疗器械规定使用期限终止 后五年。Chapter V Handling of Safety Incidents
24、Involving the Use of Medical Devices第五章 使用平安事件处理Article 36 A medical institution shall collect, analyze, evaluate and control safety incidents involving the use of medical devices, and report such incidents in a timely manner under the principle of immediate reporting of any suspected safety inciden
25、t.第三十六条医疗机构 应当对医疗器械使用平安事 件进行收集、分析、评价及 控制，遵循可疑即报的原 那么，及时报告。Article 37 Where a safety incident or a suspected safety incident involving the use of medical devices occurs or is found, the medical institution and its medical staff members shall immediately take effective measures to avoid or mitigate th
26、e damage to第三十七条发生或者 发现医疗器械使用平安事件 或者可疑医疗器械使用平安 事件时、医疗机构及其医务 人员应当立即采取有效措the patient1 s physical health, prevent expanded damage, and report to the local health administrative department at the county level.施，防止或者减轻对患者身 体健康的损害，防止损害扩 大，并向所在地县级卫生健13康主管部门报告。第三十八条发生或者 发现因医疗器械使用行为导 致或者可能导致患者死亡、 残疾或者二人以上人身损
27、害 时，医疗机构应当在二十四 小时内报告所在地县级卫生 健康主管部门，必要时可以 同时向上级卫生健康主管部 门报告。医疗机构应当立即 对医疗器械使用行为进行调 查、核实；必要时，应当对 发生使用平安事件的医疗器 械同批次同规格型号库存产 品暂缓使用，对剩余产品进 行登记封存。第三十九条县级及设Article 38 Where the use of medical devices causes or may cause death or disability of a patient or personal injury to two or more patients, the medical
28、institution shall report to the local health administrative department at the county level within 24 hours upon the occurrence or discovery thereof, and when necessary, may also report to the health administrative department at a higher level. The medical institution shall immediately conduct invest
29、igations on and verify the use of the medical device; and when necessary, shall temporarily suspend the use of the same specification and model of stock medical devices in the same batch as the medical device involved in the safety incident, and register and seal up the remaining products.区的市级卫生健康主管
30、部门 获知医疗机构医疗器械使用 平安事件或者可疑医疗器械 使用平安事件后，应当进行 核实，必要时应当进行调 查；对医疗机构医疗器械使 用行为导致或者可能导致患 者死亡、残疾或者二人以上 人身损害的，应当进行现场 调查，并将调查结果逐级上 报至省级卫生健康主管部门。Article 39 Once a health administrative department at the county level or at the level of a district city acquires any information about a medical institutions safety i
31、ncident or suspected safety incident involving the use of medical devices, it shall verify the information, and when necessary, shall conduct investigations; where the use of medical devices by a medical institution causes or may cause death or disability of a patient or personal injury to two or mo
32、re patients, it shall conduct on-site investigations, and submit the investigation results to the provincial health administrative department on a level-by-level basis.省级以上卫生健康主管部门 获知医疗机构医疗器械使用Once a health administrative department at or abovethe provincial level acquires any information about a14平
33、安事件或者可疑医疗器械 使用平安事件，认为应当开 展现场调查的，应当组织开 展调查。省级卫生健康主管 部门开展相关调查的，应将 调查结果及时报送国家卫生 健康委。平安事件或者可疑医疗器械 使用平安事件，认为应当开 展现场调查的，应当组织开 展调查。省级卫生健康主管 部门开展相关调查的，应将 调查结果及时报送国家卫生 健康委。medical institutions safety incident or suspected safety incident involving the use of medical devices, it shall organize and conduct on-
34、site investigations as it deems it necessary to conduct such investigations. Where a health administrative department at the provincial level conducts relevant investigations, it shall submit the investigation results to the NHC in a timely manner.对卫生健康主管部门开展的 医疗器械使用平安事件调 查，医疗机构应当配合。The medical inst
35、itution shall cooperate with the investigations on its safety incident involving the use of medical devices conducted by the health administrative department.第四十条县级以上地 方卫生健康主管部门在医疗 器械使用平安事件调查结果 确定前，对可疑医疗器械质 量问题造成患者损害的，应 当根据影响采取相应措施； 对影响较大的，可以采取风 险性提示、暂停辖区内医疗 机构使用同批次同规格型号 的医疗器械等措施，以有效 降低风险，并通报同级药品 监督
36、管理部门。Article 40 Before the investigation results of a safety incident involving the use of medical devices are ascertained, local health administrative departments at or above the county level shall take the corresponding measures according to the impacts of the incident if any suspected quality pro
37、blem of medical devices causes damage to patients; with respect to those with great impacts, may take such measures as giving risk warnings and suspending the use of the same specification and model of medical devices in the same batch by the medical institutions within their respective jurisdiction
38、s to effectively reduce risks, and shall notify the medical products administrations at the same levels.经调查不属于医疗器械使用 平安事件的，卫生健康主管 部门应当移交同级药品监督 管理部门处理。第六章监督管理If the above incident is not a safety incident involving the use of medical devices after investigation, the health administrative department s
39、hall transfer it to the medical products administration at the same level for handling.Chapter VI Supervision and Administration15Article 41 A local health administrative department at or above the county level shall prepare and implement an annual supervisory inspection plan for the use of medical
40、devices by medical institutions within its administrative region, and determine the focus, frequency and coverage of the supervisory inspections. Medical institutions using medical devices with high risks and special storage and management requirements shall be subject to priority supervision.第四十一条县
41、级以上 地方卫生健康主管部门应当 编制并实施本行政区域医疗 机构医疗器械使用年度监督 检查计划，确定监督检查的 重点、频次和覆盖率。对使 用风险较高、有特殊保存管 理要求医疗器械的医疗机构 应当实施重点监管。Article 42 A local health administrative department at or above the county level shall strengthen the supervision and administration of the clinical use of medical devices at medical institutions,
42、 and have the power to perform the following duties during supervisory inspections:第四十二条县级以上 地方卫生健康主管部门应当 加强对医疗机构医疗器械临 床使用行为的监督管理，并 在监督检查中有权行使以下 职责：(1) Conducting on-site inspections and taking samples by entering the sites.（一）进入现场实施检查、 抽取样品；（二）查阅、复制有关档 案、记录及其他有关资料；(3) Other duties prescribed by law
43、s and regulations.（三）法律法规规定的其他 职责。(2) Consulting and copying the relevant archives, records and other relevant materials.医疗机构应当积极配合卫生 健康主管部门的监督检查， 并对检查中发现的问题及时 进行整改。第四十三条县级以上Medical institutions shall actively cooperate with the supervisory inspections by health administrative departments, and make
44、rectification in a timely manner once they are found to have problems in the inspections.Article 43 A local health administrative department at16or above the county level shall, on a regular or unscheduled basis, conduct random inspections of the administration of the clinical use of medical devices
45、 at medical institutions, and include the results of the random inspections in the medical institution supervision and administration archives.地方卫生健康主管部门应当 组织对医疗机构医疗器械临 床使用管理情况进行定期或 者不定期抽查，并将抽查结 果纳入医疗机构监督管理档 案。Chapter VII Legal Liability第七章法律责任Article 44 Where a medical institution falls under any o
46、f the following circumstances, the local health administrative department at or above the county level shall punish it according to the relevant provisions of the Regulation on the Supervision and Administration of Medical Devices:第四十四条 医疗机构 有以下情形之一的，由县级 以上地方卫生健康主管部门 依据医疗器械监督管理条 例的有关规定予以处理：(1) Faili
47、ng to establish and implement a record system for checking purchased medical devices as required.（一）未按照规定建立并执 行医疗器械进货查验记录制 度的；(2) Failing to dispose of reused medical devices according to the provisions on disinfection and management.（二）对重复使用的医疗器 械，未按照消毒和管理的规 定进行处理的；(3) Reusing disposable medical de
48、vices, or failing to destroy used disposable medical devices as required.（三）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 的医疗器械的；(4) Failing to properly preserve the original information on the purchase of Class III medical devices, or failing to retain the information on large- scale medical devices and implantable and interventional medical devices in the medical records and other relevant records as required.（四）未妥善保存购入第三 类医疗器械的原始资料，或 者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 记录中的；17（五）发现使用的医疗器械 存在平安