（精选）医疗器械不良事件监测和再评价-英文Word版

1、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 Adverse Events(Decree No.1 by State Administration for Market Regulation)2018年08月31日 发布Released 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。Measure

2、s for the Management of the Monitoring and Reevaluation of Medical Device Adverse Events has been reviewed and approved by State Administration for Market Regulation and National Health Commision, and now is promulgated and effective as of January 1, 2019. 国家市场监督管理总局局长：张茅Director General of State Ad

3、ministration for Market Regulation: Zhangmao国家卫生健康委员会主任：马晓伟Director of National Health Commision: Ma Xiaowei2018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 Adverse Events第一章 总 则Chapter IGeneral Provisions第一条 为加强医疗器械不良事件监测和再评

4、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 1In order to strengthen the monitoring and reevaluation of medical device adverse 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

5、the Monitoring and Reevaluation of Medical Device Adverse 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 2The Measures shall apply to the

6、monitoring, reevaluation and supervision and management of medical device adverse events carried out within the Peoples 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 3Me

7、dical 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 adverse event monitoring system, and directly

8、 report adverse events of medical devices to the technical institution for the monitoring of adverse events of medical devices (hereinafter referred to as “the monitoring institution”). The operating enterprise authorized by the holder to sell medical devices and the medical device using unit shall

9、report medical device adverse 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 adverse events found, improve the product quality according to the evaluation results, and report the evaluation re

10、sults 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

11、the overseas holder shall undertake the monitoring of the adverse events of imported medical devices sold within PRC and cooperate with the overseas holder to fulfill the obligation for reevaluation.第四条 本办法下列用语的含义：Article 4The terms referred in the Measures shall have the following meanings:（一）医疗器械上

12、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

13、。(II)Medical device adverse event refers to all kinds of harmful events of marketed medical devices that occur under normal use of the medical devices and cause or possibly cause 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-th

14、reatening;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

15、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 adverse event refers to the event that occurs in a relatively concentrated time and area during the use of the same medical device and causes 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

16、件的收集、报告、调查、分析、评价和控制的过程。(V)Monitoring of medical device adverse event refers to the process of collecting, reporting, investigation, analysis, evaluation and control of medical device adverse events.（六）医疗器械重点监测，是指为研究某一品种或者产品上市后风险情况、特征、严重程度、发生率等，主动开展的阶段性监测活动。(VI)Intensive monitoring of medical device

17、refers to the phased monitoring activities carried out with initiative to study the post-market risks, characteristics, severity and incidence rate of a certain variety or product.（七）医疗器械再评价，是指对已注册或者备案、上市销售的医疗器械的安全性、有效性进行重新评价，并采取相应措施的过程。(VII)Medical device reevaluation refers to the process in which

18、 the safety and effectiveness of the medical devices registered or filed or marketed are reevaluated and appropriate measures are taken.第五条 国家药品监督管理局建立国家医疗器械不良事件监测信息系统，加强医疗器械不良事件监测信息网络和数据库建设。Article 5State Drug Administration (SDA) shall establish the national monitoring information system for adver

19、se events of medical devices and strengthen the construction of medical device adverse event monitoring information network and database.国家药品监督管理局指定的监测机构（以下简称国家监测机构）负责对收集到的医疗器械不良事件信息进行统一管理，并向相关监测机构、持有人、经营企业或者使用单位反馈医疗器械不良事件监测相关信息。The monitoring institution designated by SDA (hereinafter referred to a

20、s “the national monitoring institution”) is responsible for the unified management of the information concerning the medical device adverse event collected and feedback the information relating to the monitoring of medical device adverse events back to relevant monitoring institution, holder, operat

21、ing enterprise or using unit.与产品使用风险相关的监测信息应当向卫生行政部门通报。The monitoring information related to the risk of product application shall be notified to the health administrative department.第六条 省、自治区、直辖市药品监督管理部门应当建立医疗器械不良事件监测体系，完善相关制度，配备相应监测机构和人员，开展医疗器械不良事件监测工作。Article 6The drug regulatory authorities of p

22、rovinces, autonomous regions and municipalities directly under the central government shall establish a Medical Device Adverse Event Monitoring System, improve relevant rules and regulations, assign corresponding monitoring institutions and personnel, and carry out monitoring of medical device adver

23、se events.第七条 任何单位和个人发现医疗器械不良事件，有权向负责药品监督管理的部门（以下简称药品监督管理部门）或者监测机构报告。Article 7Any institution or individual that finds adverse events in medical devices shall have the right to report them to the department in charge of drug supervision and administration (hereinafter referred to as the drug regulat

24、ory authority) or the monito ring institution. 第二章 职责与义务Chapter IIResponsibilities and Obligations第八条 国家药品监督管理局负责全国医疗器械不良事件监测和再评价的监督管理工作，会同国务院卫生行政部门组织开展全国范围内影响较大并造成严重伤害或者死亡以及其他严重后果的群体医疗器械不良事件的调查和处理，依法采取紧急控制措施。Article 8SDA shall be responsible for nationwide supervision and administration of monitori

25、ng and reevaluation of adverse events of medical devices, working with health administrative department under the State Council to organize and carry out investiagation and disposal of mass medical device adverse events that have a big impact and cause serious injury or death and other serious conse

26、quences nationwide and take emergency control measures in accordance with the relevant laws. 第九条 省、自治区、直辖市药品监督管理部门负责本行政区域内医疗器械不良事件监测和再评价的监督管理工作，会同同级卫生行政部门和相关部门组织开展本行政区域内发生的群体医疗器械不良事件的调查和处理，依法采取紧急控制措施。Article 9The drug regulatory authorities of provinces, autonomous regions and municipalities directl

27、y under the central government shall be responsible for the supervision and management on the monitoring and reevaluation of medical device adverse events within respective administrative areas, and organize and conduct the investigation and handling of mass medical device adverse event occurred wit

28、hin respective administrative areas in conjunction with health administrative department and relevant department at the same level, and take emergency control measures in accordance with law.设区的市级和县级药品监督管理部门负责本行政区域内医疗器械不良事件监测相关工作。Municipal and county-level drug regulatory authorities with districts

29、shall be responsible for the monitoring of medical device adverse events within their respective administrative areas.第十条 上级药品监督管理部门指导和监督下级药品监督管理部门开展医疗器械不良事件监测和再评价的监督管理工作。Article 10The drug regulatory authority at a higher level shall guide and supervise the supervision and management on the monitor

30、ing and reevaluation of medical device adverse events carried out by the drug regulatory authority at a lower level.第十一条 国务院卫生行政部门和地方各级卫生行政部门负责医疗器械使用单位中与医疗器械不良事件监测相关的监督管理工作，督促医疗器械使用单位开展医疗器械不良事件监测相关工作并组织检查，加强医疗器械不良事件监测工作的考核，在职责范围内依法对医疗器械不良事件采取相关控制措施。Article 11The health administrative department unde

31、r the State Council and local of health administrative departments at all levels shall be responsible for the supervision and management relating to the monitoring of medical device adverse event in the using unit of medical devices, supervise and urge medical device using unit to carry out the orga

32、nizing and inspection on the monitoring of medical device adverse events, strengthen the assessment of the monitoring of medical device adverse events, and take relevant control measures for medical device adverse events according to law within the terms of reference.上级卫生行政部门指导和监督下级卫生行政部门开展医疗器械不良事件监

33、测相关的监督管理工作。The health administrative department at a higher level shall guide and supervise the health administrative department at a lower level to carry out supervision and management related to the monitoring of medical device adverse events.第十二条 国家监测机构负责接收持有人、经营企业及使用单位等报告的医疗器械不良事件信息，承担全国医疗器械不良事件

34、监测和再评价的相关技术工作；负责全国医疗器械不良事件监测信息网络及数据库的建设、维护和信息管理，组织制定技术规范和指导原则，组织开展国家药品监督管理局批准注册的医疗器械不良事件相关信息的调查、评价和反馈，对市级以上地方药品监督管理部门批准注册或者备案的医疗器械不良事件信息进行汇总、分析和指导，开展全国范围内影响较大并造成严重伤害或者死亡以及其他严重后果的群体医疗器械不良事件的调查和评价。Article 12The national monitoring institution shall be responsible for receiving the information of medic

35、al device adverse events reported by the holder, operating enterprise and using unit, and shall undertake the technical work related to the monitoring and reevaluation of nationwide medical device adverse events; be responsible for the construction, maintenance and information management of the nati

36、onal medical device adverse event monitoring information network and database and to organize the formulation of technical specifications and guiding principles, organize and carry out the investigation, evaluation and feedback of the information related to adverse events of medical devices approved

37、 to register by SDA, summarize, analyze and guide the information of adverse events of medical devices approved to register or file by the local drug regulatory authorities at or above the municipal level, and carry out investigation and evaluation on mass medical device adverse events that have gre

38、at impact across country and have caused serious injury or death and other serious consequences.第十三条 省、自治区、直辖市药品监督管理部门指定的监测机构（以下简称省级监测机构）组织开展本行政区域内医疗器械不良事件监测和再评价相关技术工作；承担本行政区域内注册或者备案的医疗器械不良事件的调查、评价和反馈，对本行政区域内发生的群体医疗器械不良事件进行调查和评价。Article 13The monitoring institutions designated by the drug regulatory

39、 authorities of provinces, autonomous regions and municipalities directly under the central government (hereinafter referred to as “the provincial monitoring institutions”) shall organize the technical work related to the monitoring and reevaluation of adverse events of medical devices within their

40、respective administrative areas; undertake the investigation, evaluation and feedback of the adverse events of the medical devices registered or recorded within the administrative area, and investigate and evaluate mass medical device adverse events in the administrative area.设区的市级和县级监测机构协助开展本行政区域内医

41、疗器械不良事件监测相关技术工作。Municipal and county-level monitoring institution with districts shall assist in the technical work related to the monitoring of medical device adverse events within their respective administrative areas.第十四条 持有人应当对其上市的医疗器械进行持续研究，评估风险情况，承担医疗器械不良事件监测的责任，根据分析评价结果采取有效控制措施，并履行下列主要义务：Arti

42、cle 14The holder shall conduct continuous research on its medical devices available on market, assess the risks, assume the responsibility for monitoring adverse events of medical devices, take effective control measures according to the analysis and evaluation results, and perform the following mai

43、n obligations:（一）建立包括医疗器械不良事件监测和再评价工作制度的医疗器械质量管理体系；(I)Establish the quality management system for medical devices including the monitoring and reevaluation of medical device adverse events;（二）配备与其产品相适应的机构和人员从事医疗器械不良事件监测相关工作；(II)Allocate the institutions and personnel appropriate to its products to e

44、ngage in the monitoring of medical device adverse events;（三）主动收集并按照本办法规定的时限要求及时向监测机构如实报告医疗器械不良事件；(III)Take the initiative to collect and truthfully report the adverse events of medical devices to the monitoring institutions in a timely manner in accordance with the time limit stipulated in the Measu

45、res;（四）对发生的医疗器械不良事件及时开展调查、分析、评价，采取措施控制风险，及时发布风险信息；(IV)Carry out timely investigation, analysis and evaluation on the medical device adverse events occurred and take measures to control risks and timely release risk information;（五）对上市医疗器械安全性进行持续研究，按要求撰写定期风险评价报告；(V)Conduct continuous research on the s

46、afety of the marketed medical devices and prepare periodic risk evaluation reports as required;（六）主动开展医疗器械再评价；(VI)Conduct medical device reevaluation with initiative;（七）配合药品监督管理部门和监测机构组织开展的不良事件调查。(VII)Cooperate with drug regulatory authorities and monitoring institutions to organize the investigatio

47、n of adverse events.第十五条 境外持有人除应当履行本办法第十四条规定的义务外，还应当与其指定的代理人之间建立信息传递机制，及时互通医疗器械不良事件监测和再评价相关信息。Article 15In addition to the obligations set forth in Article 14 of the Measures, the overseas holder shall also establish an information transmission mechanism with its designated agent to timely exchange

48、information on the monitoring and reevaluation of adverse events of medical devices.第十六条 医疗器械经营企业、使用单位应当履行下列主要义务：Article 16Medical device operating enterprises or using units shall fulfill the following main obligations:（一）建立本单位医疗器械不良事件监测工作制度，医疗机构还应当将医疗器械不良事件监测纳入医疗机构质量安全管理重点工作；(I)Establish the worki

49、ng system for the monitoring of adverse events of medical devices in the unit; medical institutions should also incorporate the monitoring of adverse events of medical devices into the key work of the quality and safety management of medical institutions;（二）配备与其经营或者使用规模相适应的机构或者人员从事医疗器械不良事件监测相关工作；(II

50、)Allocate the institutions or personnel appropriate to its operating or using scale to engage in the monitoring of medical device adverse events;（三）收集医疗器械不良事件，及时向持有人报告，并按照要求向监测机构报告；(III)Collect adverse events of medical devices, report them to the holder in a timely manner, and report them to the mo

51、nitoring institutions as required;（四）配合持有人对医疗器械不良事件的调查、评价和医疗器械再评价工作；(IV)Cooperate with the holder in the investigation, evaluation and reevaluation of medical device adverse events;（五）配合药品监督管理部门和监测机构组织开展的不良事件调查。(V)Cooperate with drug regulatory authorities and monitoring institutions to organize the

52、 investigation of adverse events.第三章 报告与评价Chapter IIIReporting and Evaluation第一节 基本要求Section IBasic Requirements第十七条 报告医疗器械不良事件应当遵循可疑即报的原则，即怀疑某事件为医疗器械不良事件时，均可以作为医疗器械不良事件进行报告。Article 17The reporting of adverse events of medical devices should follow the principle of reporting as suspected, i.e., when

53、 an event is suspected to be an adverse event of medical device, it can be reported as an adverse event of medical device.报告内容应当真实、完整、准确。The report shall be authentic, complete and accurate.第十八条 导致或者可能导致严重伤害或者死亡的可疑医疗器械不良事件应当报告；创新医疗器械在首个注册周期内，应当报告该产品的所有医疗器械不良事件。Article 18Suspicious adverse events of

54、medical devices causing or possibly causing serious injury or death shall be reported; during the initial registration cycle, all adverse events of medical devices of the product should be reported.第十九条 持有人、经营企业和二级以上医疗机构应当注册为国家医疗器械不良事件监测信息系统用户，主动维护其用户信息，报告医疗器械不良事件。持有人应当持续跟踪和处理监测信息；产品注册信息发生变化的，应当在系统中

55、立即更新。Article 19The holders, operating enterprises and medical institutions at or above Level 2 shall be registered as the users of the national medical device adverse events monitoring information system, actively maintain the information of their users and report adverse events of medical devices.

56、The holder shall continuously track and handle the monitoring information; if the product registration information changes, it shall be updated immediately in the system.鼓励其他使用单位注册为国家医疗器械不良事件监测信息系统用户，报告不良事件相关信息。Other users are encouraged to register as the users of the national medical device advers

57、e event monitoring information system and report the information of relevant adverse event.第二十条 持有人应当公布电话、通讯地址、邮箱、传真等联系方式，指定联系人，主动收集来自医疗器械经营企业、使用单位、使用者等的不良事件信息；对发现或者获知的可疑医疗器械不良事件，持有人应当直接通过国家医疗器械不良事件监测信息系统进行医疗器械不良事件报告与评价，并上报群体医疗器械不良事件调查报告以及定期风险评价报告等。Article 20The holder shall publish contact informat

58、ion such as telephone number, mailing address, email address, fax, etc., designate contacts, and take the initiative to collect information of adverse events from medical device operating enterprises, using units and users; for suspected medical device adverse events found or known, the holder shall report and evaluate the medical device adverse events directly through the national medical device adverse events monitoring information system, and submit mass medical device adverse event investigation report and periodic risk evaluation report.医疗器械经营企业、使用单位发现