【中英文对照版】医疗器械不良事件监测和再评价管理办法.docx

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1、医疗器械不良事件监测和再评价管理方法Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation【中英文对照版】发布部门：国家市场监督管理总局国家卫生健康委员会发文字号：国家市场监督管理总局、中华人民共和国国家卫生健康委员会令第1号发布日期：实施日期：效力级别：部门规章法规类别：医疗器械药品药材进出口Issuing Authority : State Administration for Market Regulation National Health Commissi

2、on Document Number : Order No. 1 of the State Administration for Market Regulation and the National Health CommissionDate Issued ： 08-13-2018Effective Date ： 01-01-2019Level of Authority : Departmental RulesArea of Law : Import and Export of Medical Devices, Drugs, and Medicine Materials(No. 1)(No.

3、1)Order of the State Administration for Market 国家市场监督管理总局、中 Regulation and the National Health Commission of the 华人民共和国国家卫生健康 Peoples Republic of China委员会令医疗器械不良事件监测和 再评价管理方法已经国家 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。医疗器械不良事件监测和 再评价管理方法已经国家 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。市场监督管理总

4、局局长：张卫生健康委员会主任：马晓伟（第1号）The Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation, as deliberated and adopted by the State Administration for Market Regulation and the National Health Commission, are hereby issued and shall come into force on January 1, 2019.Dir

5、ector of the State Administration for MarketRegulation: Zhang MaoDirector of the National Health Commission: Ma XiaoweiAugust 13, 2018August 13, 20182018年8月13日event monitoring and re-evaluation of medical devices.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 16 A medical device operation enterprise or user

6、entity shall perform the following main obligations:第十六条医疗器械经 营企业、使用单位应当履行 以下主要义务：(1) Establishing a working system for monitoring its )建立本单位医疗有械 medical device adverse events, and a medical 不良事件监测工作制度,医 institution shall also incorporate the monitoring of 疗机构还应当将医疗器械不 medical device adverse events

7、into the priority work of 良事件监测纳入医疗机构质 quality safety management of medical institutions,量平安管理重点工作；(2) Assigning institutions or personnel suitable for its operation or use scale to engage in the work relating to the monitoring of medical device adverse events.（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

8、测相关工作；(3) Collecting medical device adverse events, reporting to the licensee in a timely manner, and reporting to the monitoring agency as required.（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；(4) Cooperating with the licensee in investigation and evaluation of medical device adverse events and re-（四）配合持有

9、人对医疗器 械不良事件的调查、评价和evaluation of medical devices.医疔器械再评价工作;(5) Cooperating with the drug administration and the monitoring agency in organizing and conducting the investigation of 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。Chapter III Reporting and Evaluation第三章报告与评价10Section 1 Basic Requirements

10、第一节基本要求Article 17 Medical device adverse events shall be reported according to the principle of immediate reporting on suspicion, to wit: a suspected medical device adverse event may be reported as a medical device adverse event.第十七条报告医疗器 械不良事件应当遵循可疑即 报的原那么，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。The

11、content of a report shall be authentic, complete and accurate.报告内容应当真实、 准确。完整、Article 18 A suspected medical device adverse event that results in or may result in serious impairment or death shall be reported; and in the first registration cycle of innovative medical devices, all medical device adve

12、rse events relating to the products shall be reported.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。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，应当在系统中立即更第十九条持有人、经Article 19 A licensee, operation enterprise, or medical 营企业和二级 以上医疗机构ins

13、titution at or above Class II shall be registered as a user of the National Medical Device Adverse Event Monitoring Information System, vigorously maintain its user information, and report medical device adverse events. A licensee shall continuously track and process monitoring information; and if a

14、ny change is made to product registration information, it shall be immediately updated in the system.新。11Other user entities shall be encouraged to be registered as users of the National Medical Device Adverse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。第二十条持有人应当Event Monitoring Information System and

15、report information on adverse events.公布 、通讯地址、邮 箱、 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疔 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Article 20 A licensee shall publish its contact information such as telephone number, mailing address, e-mail a

16、ddress, and fax number, designate a point of contact, and actively collect information on adverse events from medical device operation enterprises, user entities, and users, among others; and for a suspected medical device adverse event discovered or known, the licensee shall directly report and eva

17、luate the medical device adverse event through the National Medical Device Adverse Event Monitoring Information System and submit group medical device adverse event investigation reports and periodic risk evaluation reports, among others.价报告等。医疗器械经营企业、使用单位发现或者获知可疑医疗器 械不良事件的，应当及时告 知持有人，并通过国家医疗 器械不良事件

18、监测信息系统 报告。暂不具备在线报告条 件的，应当通过纸质报表向 所在地县级以上监测机构报 告，由监测机构代为在线报 告。各级监测机构应当公布电 话、通讯地址等联系方式。If a medical device operation enterprise or user entity discovers or becomes aware of a suspected medical device adverse event, it shall promptly inform the licensee and report through the National Medical Device Ad

19、verse Event Monitoring Information System. If there is no online reporting condition, a report shall be made to the local monitoring agency at or above the county level in hard copy, and the monitoring agency shall report online on behalf.The monitoring agencies at all levels shall release their con

20、tact information such as telephone numbers and mailing address.12Article 21 A licensee shall analyze and evaluate the information on the monitoring of medical device adverse events collected and known and actively carry out medical device safety research. For medical devices approved on condition, t

21、he licensee shall also conduct relevant work in accordance with the risk management and control plan.第二十一条持有人应 当对收集和获知的医疗器械 不良事件监测信息进行分 析、评价，主动开展医疗器 械平安性研究。对附条件批 准的医疗器械，持有人还应 当按照风险管控计划开展相 关工作。第二十二条持有人、Article 22 Licensees, operation enterprises and user 经营企业、使用单位应当建 entities shall establish and keep

22、 monitoring records of 立并保存医疗器械不良事件 medical device adverse events. The records shall be kept for two years after the expiration date of a medical device; and if there is no expiration date, the keeping period shall not be less than five years. The monitoring records of implantable medical devices sh

23、all be kept indefinitely and medical institutions shall keep them in accordance with case-related provisions.监测记录。记录应当保存至 医疗器械有效期后2年；无 有效期的，保存期限不得少 于5年。植入性医疗器械的 监测记录应当永久保存，医 疗机构应当按照病例相关规 定保存。Article 23 Provincial monitoring agencies shall comprehensively analyze the adverse event reports on medical

24、devices registered or filed in their respective administrative regions, propose regulatory measures against the risk discovered, and report to the drug administrations of corresponding provinces, autonomous regions, or municipalities directly under the Central Government and the national monitoring

25、agency within 30 days after the end of each quarter.The national monitoring agency shall comprehensively analyze the adverse event reports on the medical devices whose registration or filing is approved by the第二十三条省级监测 机构应当对本行政区域内注 册或者备案的医疗器械的不 良事件报告进行综合分析， 对发现的风险提出监管措施 建议，于每季度结束后30 日内报所在地省、自治区、 直辖市

26、药品监督管理部门和 国家监测机构。第二十三条省级监测 机构应当对本行政区域内注 册或者备案的医疗器械的不 良事件报告进行综合分析， 对发现的风险提出监管措施 建议，于每季度结束后30 日内报所在地省、自治区、 直辖市药品监督管理部门和 国家监测机构。国家监测机构应当对国家药 品监督管理局批准注册或者 备案的医疗器械的不良事件13State Drug Administration and the quarterly reports from the drug administrations of provinces, autonomous regions and municipalities d

27、irectly under the Central Government and propose regulatory measures to the State Drug Administration if necessary.报告和各省、自治区、直辖 市药品监督管理部门的季度 报告进行综合分析，必要时 向国家药品监督管理局提出 监管措施建议。Article 24 Provincial monitoring agencies shall consolidate and analyze the adverse event reports on medical devices registere

28、d or filed in their respective administrative regions on a yearly basis, prepare an annual consolidated report, and report to the drug第二十四条省级监测 机构应当按年度对本行政区 域内注册或者备案的医疗器 械的不良事件监测情况进行 汇总分析，形成年度汇总报administrations of corresponding provinces, autonomous regions, or municipalities directly under the Cent

29、ral Government and the national monitoring agency prior to March 15 each year.告，于每年3月15日前报 所在地省、自治区、直辖市 药品监督管理部门和国家监 测机构。The national monitoring agency shall consolidate and analyze the annual monitoring information on medical device adverse events nationwide, prepare an annual report, and report to

30、 the State Drug Administration before the end of March each year.国家监测机构应当对全国医 疗器械不良事件年度监测情 况进行汇总分析，形成年度 报告，于每年3月底前报国 家药品监督管理局。The drug administrations at or above the provincial level shall notify the health departments at the same level of annual reports.省级以上药品监督管理部门 应当将年度报告情况通报同 级卫生行政部门。Section 2

31、Individual Medical Device Adverse Events第二节个例医疗器械不良 事件第二十五条持有人发 现或者获知可疑医疗器械不 良事件的，应当立即调查原Where a licensee discovers or becomes aware of a suspected medical device adverse event, it shall immediately investigate the cause and, if death14因，导致死亡的应当在7日 内报告；导致严重伤害、可 能导致严重伤害或者死亡的 应当在20日内报告。因，导致死亡的应当在7日 内报

32、告；导致严重伤害、可 能导致严重伤害或者死亡的 应当在20日内报告。医疗器械经营企业、使用单results, report within seven days; or, if serious impairment results, or serious impairment or death may result, within 20 days.位发现或者获知可疑医疗器 械不良事件的，应当及时告 知持有人。其中，导致死亡 的还应当在7日内，导致严 重伤害、可能导致严重伤害 或者死亡的在20日内，通 过国家医疗器械不良事件监 测信息系统报告。第二十六条除持有If a medical device

33、 operation enterprise or user entity discovers or becomes aware of a suspected medical device adverse event, it shall promptly inform the licensee. If death results, a report shall be made through the National Medical Device Adverse Event Monitoring Information System Report within seven days or, if

34、 serious impairment results, or serious impairment or death may result, within 20 days.人、经营企业、使用单位以 外的其他单位和个人发现导 致或者可能导致严重伤害或 者死亡的医疗器械不良事件 的，可以向监测机构报告， 也可以向持有人、经营企业 或者经治的医疗机构报告， 必要时提供相关的病历资料。Article 25 Where an entity or individual other than the licensee, operation enterprise or user entity discove

35、rs a medical device adverse event that causes or may cause serious impairment or death, a report may be made to the monitoring agency, or to the licensee, operation enterprise, or medical institution in which treatment is received, and provide relevant medical records when necessary.第二十七条进口医疗 器械的境外持

36、有人和在境外 销售国产医疗器械的持有 人，应当主动收集其产品在 境外发生的医疗器械不良事 件。其中，导致或者可能导 致严重伤害或者死亡的，境 外持有人指定的代理人和国An overseas licensee of imported medical devices, or a licensee that sells domestically produced medical devices overseas shall take the initiative to collect medical device adverse events that occur overseas in relat

37、ion to its products. If serious impairment or death results or may result, the agent designated by the overseas licensee and the licensee of domestically produced medical devices shall report within 30 days from the date of discovery or15knowledge.knowledge.产医疗器械持有人应当自发 现或者获知之日起30日内 报告。第二十八条设区的市 级监测

38、机构应当自收到医疗 器械不良事件报告之日起 10日内，对报告的真实 性、完整性和准确性进行审 核，并实时反应相关持有 人。第二十九条持有人在Monitoring agencies of cities divided into districts shall, within ten days from the date of receiving the adverse event report on medical devices, review the authenticity, integrity, and accuracy of the reports and provide feedba

39、ck for the relevant licensees instantaneously.报告医疗器械不良事件后或 者通过国家医疗器械不良事 件监测信息系统获知相关医MedicalDeviceAdverse Event Monitoring疗器械不良事件后，应当按A licensee shall, after reporting a medical device adverse event, or becoming aware of a relevant medical device adverse event through the National要求开展后续调查、分析和 评价，导致死亡

40、的事件应当 在30日内，导致严重伤 害、可能导致严重伤害或者 死亡的事件应当在45日内 向持有人所在地省级监测机 构报告评价结果。对于事件情况和评价结果有新的发现 或者认知的，应当补充报第三十条持有人所在 地省级监测机构应当在收到 持有人评价结果10日内完 成对评价结果的审核，必要Information System, conduct subsequent investigation, analysis and evaluation as required and, if death results therefrom, report on evaluation results to the

41、provincial monitoring agency in the place where the licensee is located within 30 days or, if serious impairment results, or serious impairment or death may result therefrom, within 45 days. If there is new finding or understanding of the circumstances of the event and the evaluation results, the re

42、port shall be supplemented.Article 26 The provincial monitoring agency in the place where the licensee is located shall complete the review of the evaluation results within ten days of receiving the evaluation results from the licensee and if necessary, may commission the provincial16monitoring agen

43、cy in the place of the occurrence of 时可以委托或者会同不良事件发生地省级监测机构对导 致或者可能导致严重伤害或 者死亡的不良事件开展现场 调查。其中，对于国家药品 监督管理局批准注册的医疗 器械，国家监测机构还应当 对省级监测机构作出的评价adverse event to, or in conjunction with the same, conduct an on-site investigation of the adverse event that results in or may result in serious impairment or d

44、eath. For medical devices whose registration is approved by the State Drug Administration, the national monitoring agency shall also review the review results of evaluations from provincial monitoring agencies, and if necessary, may organize an investigation into adverse events resulting in death. 审

45、核结 果进行 复核， 必要时可以组织对导致死亡的不良 事件开展调查。审核和复核结果应当反应持 有人。对持有人的评价结果 存在异议的，可以要求持有 人重新开展评价。Section 3 Group Medical Device Adverse Events第三节群体医疗器械不良 事件The feedback on review results shall be provided for the licensee. If there is any disagreement with a licensees evaluation results, the licensee may be require

46、d to conduct another evaluation.经营企业、使用单位发现或 者获知群体医疗器械不良事 件后，应当在12小时内通 过 或者 等方式报告 不良事件发生地省、自治 区、直辖市药品监督管理部 门和卫生行政部门，必要时 可以越级报告，同时通过国 家医疗器械不良事件监测信 息系统报告群体医疗器械不 良事件基本信息，对每一事 件还应当在24小时内按个第三十一条持有人、Article 31 A licensee, operation enterprise, or user entity shall, within 12 hours after discovering or bec

47、oming aware of a group medical device adverse event, report to the drug administration and health department of the province, autonomous region, or municipality directly under the Central Government where the adverse event occurs by telephone, fax, or any other means or, if necessary, may report by

48、the leapfrog procedure, and shall report the basic information of the group medical device adverse event through the National Medical Device Adverse Event Monitoring Information System and report each event as an individual event within 24 hours.例事件报告。17不良事件发生地省、自治 区、直辖市药品监督管理部不良事件发生地省、自治 区、直辖市药品监督管理部The drug administration of the province, autonomous region, or municipality directly und