《医疗器械不良事件监测和再评价管理办法》（国家市场监督管理总局令第1号）
Measures for the Management of the Monitoring and Reevaluation of Medical Device Adver Events
(Decree No.1 by State Administration for Market Regulation)
2018年08月31日 发布
Relead on August 31, 2018
《医疗器械不良事件监测和再评价管理办法》已经国家市场监督管理总局和国家卫生健康委员会审议通过，现予公布，自2019年1月1日起施行。
Measures for the Management of the Monitoring and Reevaluation of Medical Device Adver Events has been reviewed and approved by State Administration for Market Regulation and National Health Commision, and now is promulgated and effective as of Ja
nuary 1, 2019.
国家市场监督管理总局局长：张茅
Director General of State Administration for Market Regulation: Zhangmao
国家卫生健康委员会主任：马晓伟
Director of National Health Commision: Ma Xiaowei
2018年8月13日
August 13, 2018
医疗器械不良事件监测和再评价管理办法
Measures for the Management of the Monitoring and Reevaluation of Medical Device Adver Events
第一章总 则
Chapter I General Provisions
第一条为加强医疗器械不良事件监测和再评价，及时、有效控制医疗器械上市后风险，保障人体健康和生命安全，根据《医疗器械监督管理条例》，制定本办法。
Article 1 In order to strengthen the monitoring and reevaluation of medical device adver events, timely and effectively control the risks of post-market medical devices, and guarantee human health and life safety, the Measures for the Management of the Monitoring and Reevaluation of Medical Device Adver Events (hereinafter referred to as “the Measures”) is formulated in accordance with the Regulations for the Supervision and Administration of Medical Devices.
第二条在中华人民共和国境内开展医疗器械不良事件监测、再评价及其监督管理，适用本办法。
Article 2 The Measures shall apply to the monitoring, reevaluation and supervision and management of medical device adver events carried out within the People’s Republic of China.
第三条医疗器械上市许可持有人（以下简称持有人），应当具有保证医疗器械安全有效的质量管理能力和相应责任能力，建立医疗器械不良事件监测体系，向医疗器械不良事件监测技术机构（以下简称监测机构）直接报告医疗器械不良事件。由持有人授权销售的经营企业、医疗器械使用单位应当向持有人和监测机构报告医疗器械不良事件。
Article 3 Medical device listing approval holder (hereinafter referred to as the holder), shall have the quality management capability and the corresponding responsibility capability to ensure the safety and effectiveness of medical devices, establish medical device adver event monitoring system, and directly report adver events of medical devices to the technical institution for the monitoring of adver events of medical devices (hereinafter referred to as “the monitoring institution”). The operating enterpri authorized by the holder to ll medical devices and the medical device using unit shall report medical device adver events to the holder and the monitoring institution.
持有人应当对发现的不良事件进行评价，根据评价结果完善产品质量，并向监测机构报告评价结果和完善质量的措施；需要原注册机关审批的，应当按规定提交申请。
The holder shall evaluate the adver events found, improve the product quality according to the evaluation results, and report the evaluation results and measures for improving the quality to the monitoring institutions; if approval from the original registration authority is required, the application for approval shall be submitted according to relevant regulations.
境外持有人指定的代理人应当承担境内销售的进口医疗器械的不良事件监测工作，配合境外持有人履行再评价义务。
The agent designated by the overas holder shall undertake the monitoring of the adver events of imported medical devices sold within PRC and cooperate with the overas holder to fulfill the obligation for reevaluation.
第四条本办法下列用语的含义：
Article 4 The terms referred in the Measures shall have the following meanings:
（一）医疗器械上市许可持有人，是指医疗器械注册证书和医疗器械备案凭证的持有人，
即医疗器械注册人和备案人。
(I) Medical device listing approval holder refers to the holder of registration certificate for medical device and filing certificate for medical device, i.e., the registrant and filer of medical device.
（二）医疗器械不良事件，是指已上市的医疗器械，在正常使用情况下发生的，导致或者可能导致人体伤害的各种有害事件。
(II) Medical device adver event refers to all kinds of harmful events of marketed medical devices that occur under normal u of the medical devices and cau or possibly cau injury to human body.
（三）严重伤害，是指有下列情况之一者：
(III) Serious injury refers to any of the following circumstances:
1.危及生命；
1. Life-threatening;
2.导致机体功能的永久性伤害或者机体结构的永久性损伤；
2. Causing permanent injury to the functions of the body or permanent damage to the structure of the body;
3.必须采取医疗措施才能避免上述永久性伤害或者损伤。
3. Above permanent injury or damage which cannot be avoided until medical measures are taken.
（四）群体医疗器械不良事件，是指同一医疗器械在使用过程中，在相对集中的时间、区域内发生，对一定数量人群的身体健康或者生命安全造成损害或者威胁的事件。
(IV) Mass medical device adver event refers to the event that occurs in a relatively concentrated time and area during the u of the same medical device and caus damage or threat to the health or life safety of a certain number of people.
（五）医疗器械不良事件监测，是指对医疗器械不良事件的收集、报告、调查、分析、评价和控制的过程。
(V) Monitoring of medical device adver event refers to the process of collecting, reporting, investigation, analysis, evaluation and control of medical device adver events.
