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Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation [Effective]
医疗器械不良事件监测和再评价管理办法 [现行有效]
【法宝引证码】

Order of the State Administration for Market Regulation and the National Health Commission of the People's Republic of China 

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

(No. 1) (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. 《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。
Director of the State Administration for Market Regulation: Zhang Mao 市场监督管理总局局长:张茅
Director of the National Health Commission: Ma Xiaowei 卫生健康委员会主任:马晓伟
August 13, 2018 2018年8月13日
Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation 医疗器械不良事件监测和再评价管理办法
Chapter I General Provisions 

第一章 总 则

 
Article 1 For the purposes of strengthening the adverse event monitoring and re-evaluation of medical devices, promptly and effectively controlling the post-market risk of medical devices, and protecting the health and safety of people, these Measures are developed in accordance with the Regulation on the Supervision and Administration of Medical Devices.   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 2 These Measures shall apply to the adverse event monitoring, re-evaluation, and supervision and administration of medical devices conducted in the territory of the People's Republic of China.   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 3 A medical device marketing licensee (hereinafter referred to as the "licensee") shall have quality management capabilities for ensuring the safety and effect of medical devices and corresponding responsibility assumption capabilities and establish a medical device adverse event monitoring system to directly report medical device adverse events to medical device adverse event monitoring technical agencies (hereinafter referred to as the "monitoring agencies"). Operation enterprises authorized by licensees to sell and medical device user entities shall report medical device adverse events to the licensees and monitoring agencies.   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。
A licensee shall evaluate discovered adverse events, improve product quality according to the evaluation results, and report on the evaluation results and quality improvement measures to the monitoring agency; and if approval of the original registration authority is necessary, an application shall be submitted as required. 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 agent designated by an overseas licensee shall assume the adverse event monitoring work relating to imported medical devices sold in China and cooperate with the overseas licensee to perform the re-evaluation obligation. 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。
Article 4 Definitions of the following terms in these Measures:   第四条 本办法下列用语的含义:
(1) "Medical device marketing licensee" means a holder of a medical device registration certificate and a medical device filing certificate, to wit: the medical device registrant and filing person. (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。
(2) "Medical device adverse event" means a harmful event which occurs when a marketed medical device is in normal use and results in or may result in physical harm to human. (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。
(3) "Serious impairment" means one under any of the following circumstances: (三)严重伤害,是指有下列情况之一者:
(a) Life-threatening. 1.危及生命;
(b) Resulting in permanent impairment of a body function or permanent damage to a body structure. 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;
(c) Requiring medical measures to prevent the aforesaid permanent impairment or damage. 3.必须采取医疗措施才能避免上述永久性伤害或者损伤。
(4) "Group medical device adverse event" means an event that occurs in a relatively specific period of time or region during the use of the same medical device, causing damage or threat to the personal health or life safety of a certain number of people. (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。
(5) "Monitoring of medical device adverse events" means the process of collecting, reporting, investigating, analyzing, evaluating, and controlling medical device adverse events. (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。
(6) "Priority monitoring of medical devices" means phased monitoring activities proactively conducted in order to study the information, characteristics, severity, and incidence of the post-market risk of a variety or product. (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。
(7) "Re-evaluation of medical devices" means the process of re-evaluating the safety and effectiveness of registered or filed marketed medical devices and taking corresponding measures. (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。
Article 5 The State Drug Administration shall establish a national medical device adverse event monitoring information system and strengthen the development of the medical device adverse event monitoring information network and database.   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。
The monitoring agency designated by the State Drug Administration (hereinafter referred to as the "national monitoring agency") shall be responsible for the unified management of the collected information on medical device adverse events and give relevant monitoring agencies, licensees, operation enterprises, or user entities feedback on medical device adverse events. 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。
Monitoring information related to product use risk shall be communicated to the health authorities. 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。
Article 6 The drug supervision and administration authorities of provinces, autonomous regions and municipalities directly under the Central Government shall establish a medical device adverse event monitoring system, improve relevant systems, and assign corresponding monitoring agencies and personnel, to monitor medical device adverse events.   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 7 Any entity or individual shall have the right to report on a medical device adverse event discovered to the authority in charge of drug supervision and administration (hereinafter referred to as the "drug authority") or the monitoring agency.   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。
Chapter II Duties and Obligations 

第二章 职责与义务

 
Article 8 The State Drug Administration shall be responsible for the supervision and administration of adverse event monitoring and re-evaluation of medical devices nationwide, organize and conduct the investigation and disposition of group medical device adverse events which have a relatively significant impact nationwide and cause serious impairment or death or other serious consequences in conjunction with the health department of the State Council, and take emergency control measures according to the law.   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 9 The drug administration of a province, autonomous region, or municipality directly under the Central Government shall be responsible for the supervision and administration of the adverse event monitoring and re-evaluation of medical devices within its administrative region, organize and conduct the investigation and disposition of group medical device adverse events in conjunction with the health department and other departments at the same level, and take emergency control measures according to the law.   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。
The drug administrations at the level of city divided into districts or county shall be responsible for the monitoring of medical device adverse events in their administrative regions. 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。
Article 10 Superior drug administrations shall supervise subordinate ones supervising and administering the adverse event monitoring and re-evaluation of medical devices.   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 11 The health department of the State Council and local health departments at all levels shall be responsible for the supervision and administration related to the monitoring of medical device adverse events in medical device user entities, urge medical device user entities to carry out the work relating to the monitoring of medical device adverse events and organize inspection, strengthen the evaluation of the monitoring of medical device adverse events, and take relevant control measures with respect to medical device adverse events in accordance with the law within their remit.   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。
Superior health departments shall supervise subordinate ones conducting supervision and administration relating to the monitoring of medical device adverse events. 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测相关的监督管理工作。
Article 12 The national monitoring agency shall be responsible for receiving information on medical device adverse events reported by licensees, operation enterprises and user entities and undertake the technical work relating to adverse event monitoring and re-evaluation of medical devices nationwide; and be responsible for the establishment, maintenance and information management of a national medical device adverse event monitoring information network and database, organizing the formulation of technical specifications and guiding principles, arranging for the investigation and evaluation of and feedback on information on adverse events related to medical devices whose registration is approved by the State Drug Administration, summarizing, analyzing, and guiding the information on adverse events relating to medical devices whose registration or filing is approved by local drug administrations at or above the municipal level, and investigating and evaluating group medical device adverse events that have a relatively large impact nationwide and cause serious impairment or death or other serious consequences.   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 13 The monitoring agencies designated by the drug administrations of provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as the "provincial monitoring agencies") shall organize the relevant technical work for adverse event monitoring and re-evaluation of medical devices within their respective administrative regions; and undertake the investigation and evaluation of and feedback on adverse events relating to medical devices registered or filed within their respective administrative regions and investigate and evaluate group medical device adverse events occurring in their respective administrative regions.   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。
The monitoring agencies at the level of city divided into districts or county shall assist in the technical work related to the monitoring of medical device adverse events in their respective administrative regions. 设区的市级和县级监测机构协助开展本行政区域内医疗器械不良事件监测相关技术工作。
Article 14 A licensee shall continuously research its marketed medical devices, assess the risk situation, assume the responsibility for monitoring medical device adverse events, take effective control measures according to the results of analysis and evaluation, and perform the following main obligations:   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:
(1) Establishing a medical device quality management system that includes working rules for the adverse event monitoring and re-evaluation of medical devices. (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;
(2) Assigning institutions and personnel commensurate with their products to engage in the work relating to the monitoring 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;
(3) Proactively collecting and reporting according to the requirements for time limit as provided in these Measures on medical device adverse events to the monitoring agency. (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;
(4) Conducting timely investigation, analysis and evaluation of adverse medical device incidents, taking measures to control risk, and releasing risk information in a timely manner. (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;
(5) Conducting continuous research on the safety of marketed medical devices and preparing periodic risk evaluation reports as required. (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;
(6) Proactively re-evaluating medical devices. (六)主动开展医疗器械再评价;
(7) Cooperating in the investigation of adverse events organized and conducted by the drug administration and the monitoring agency. (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。
Article 15 An overseas licensee shall, in addition to performing the obligations as provided for in Article 14 of these Measures, establish an information transmission mechanism with their designated agents to promptly exchange information on the adverse event monitoring and re-evaluation of medical devices.   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 16 A medical device operation enterprise or user entity shall perform the following main obligations:   第十六条 医疗器械经营企业、使用单位应当履行下列主要义务:
(1) Establishing a working system for monitoring its medical device adverse events, and a medical institution shall also incorporate the monitoring of medical device adverse events into the priority work of quality safety management of medical institutions. (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;
(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-evaluation of medical devices. (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;
(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

 
Section 1 Basic Requirements 

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。
The content of a report shall be authentic, complete and accurate. 报告内容应当真实、完整、准确。
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 adverse 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。
Article 19 A licensee, operation enterprise, or medical institution 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 any change is made to product registration information, it shall be immediately updated in the system.   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,应当在系统中立即更新。
Other user entities shall be encouraged to be registered as users of the National Medical Device Adverse Event Monitoring Information System and report information on adverse events. 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。
Article 20 A licensee shall publish its contact information such as telephone number, mailing address, e-mail address, 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 evaluate 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.   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。
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 Adverse 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. 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。
The monitoring agencies at all levels shall release their contact information such as telephone numbers and mailing address. 各级监测机构应当公布电话、通讯地址等联系方式。
Article 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, the 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,主动开展医疗器械安全性研究。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。
Article 22 Licensees, operation enterprises and user entities shall establish and keep monitoring records of 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 shall be kept indefinitely and medical institutions shall keep them in accordance with case-related provisions.   第二十二条 持有人、经营企业、使用单位应当建立并保存医疗器械不良事件监测记录。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 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 agency within 30 days after the end of each quarter.   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。
The national monitoring agency shall comprehensively analyze the adverse event reports on the medical devices whose registration or filing is approved by the State Drug Administration and the quarterly reports from the drug administrations of provinces, autonomous regions and municipalities directly under the Central Government and propose regulatory measures to the State Drug Administration if necessary. 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 registered or filed in their respective administrative regions on a yearly basis, prepare an annual consolidated report, and report to the drug administrations of corresponding provinces, autonomous regions, or municipalities directly under the Central Government and the national monitoring agency prior to March 15 each year.   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 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 Individual Medical Device Adverse Events 

第二节 个例医疗器械不良事件

 
Article 25 Where a licensee discovers or becomes aware of a suspected medical device adverse event, it shall immediately investigate the cause and, if death results, report within seven days; or, if serious impairment results, or serious impairment or death may result, within 20 days.   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。
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. If death results, a report shall be made through the National Medical Device Adverse Event Monitoring Information System Report within seven days or, if serious impairment results, or serious impairment or death may result, within 20 days. 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。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。
Article 26 Where an entity or individual other than the licensee, operation enterprise or user entity discovers 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.   第二十六条 除持有人、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 27 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 relation 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 or knowledge.   第二十七条 进口医疗器械的境外持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。
Article 28 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 feedback for the relevant licensees instantaneously.   第二十八条 设区的市级监测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,并实时反馈相关持有人。
Article 29 A licensee shall, after reporting a medical device adverse event, or becoming aware of a relevant medical device adverse event through the National Medical Device Adverse Event Monitoring Information System, conduct subsequent investigation, analysis and evaluation as required and, if death results therefrom, report on evaluation results to the 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 report shall be supplemented.   第二十九条 持有人在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疗器械不良事件后,应当按要求开展后续调查、分析和评价,导致死亡的事件应当在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,应当补充报告。
Article 30 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 provincial monitoring agency in the place of the occurrence of 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 death. 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.   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审核结果进行复核,必要时可以组织对导致死亡的不良事件开展调查。
The feedback on review results shall be provided for the licensee. If there is any disagreement with a licensee's evaluation results, the licensee may be required to conduct another evaluation. 审核和复核结果应当反馈持有人。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

 
Article 31 A licensee, operation enterprise, or user entity shall, within 12 hours after discovering or becoming 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 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.   第三十一条 持有人、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小时内通过电话或者传真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小时内按个例事件报告。
The drug administration of the province, autonomous region, or municipality directly under the Central Government where an adverse event occurs shall promptly notify relevant information to the drug administration of the province, autonomous region, or municipality directly under the Central Government where the licensee is located. 不良事件发生地省、自治区、直辖市药品监督管理部门应当及时向持有人所在地省、自治区、直辖市药品监督管理部门通报相关信息。
Article 32 A licensee shall, upon discovering or becoming aware of a group medical device adverse event relating to its product, immediately suspend production or sale, notify user entities of ceasing using the relevant medical devices, conduct investigations and self-inspection of the production quality management system, and, within event days, report to the drug administrations and monitoring agencies of the provinces, autonomous regions, or municipalities directly under the Central Government where it is located and the adverse event occurs.   第三十二条 持有人发现或者获知其产品的群体医疗器械不良事件后,应当立即暂停生产、销售,通知使用单位停止使用相关医疗器械,同时开展调查及生产质量管理体系自查,并于7日内向所在地及不良事件发生地省、自治区、直辖市药品监督管理部门和监测机构报告。
The investigation shall cover the quality status of the product, the relevance of the impairment to the product, and the compliance of the operation at the use link and the circulation process, among others. Self-inspection shall cover procurement, production management, quality control, and tracking of product of the same model and the same lot, among others. 调查应当包括产品质量状况、伤害与产品的关联性、使用环节操作和流通过程的合规性等。自查应当包括采购、生产管理、质量控制、同型号同批次产品追踪等。
The licensee shall analyze the cause of the event, release risk information in a timely manner, report self-inspection information and control measures taken to the drug administrations of the provinces, autonomous regions, or municipalities directly under the Central Government where it is located and the adverse event occurs, and recall the relevant medical devices if necessary. 持有人应当分析事件发生的原因,及时发布风险信息,将自查情况和所采取的控制措施报所在地及不良事件发生地省、自治区、直辖市药品监督管理部门,必要时应当召回相关医疗器械。
Article 33 Where a medical device operation enterprise or user entity discovers or becomes aware of a group medical device adverse event, it shall inform the licensee within 12 hours, quickly conduct self-inspection, and cooperate with the licensee in conducting an investigation. The self-inspection shall cover product storage, tracking of the circulation process, and tracking of product of the same model and the same lot; and the self-inspection by the use entity shall also cover whether the use process complies with the operational specifications and product's instruction manual requirements, among others. When necessary, the medical device operation enterprise or user entity shall suspend the sale or use of the medical devices and assist relevant entities in taking relevant control measures.   第三十三条 医疗器械经营企业、使用单位发现或者获知群体医疗器械不良事件的,应当在12小时内告知持有人,同时迅速开展自查,并配合持有人开展调查。自查应当包括产品贮存、流通过程追溯,同型号同批次产品追踪等;使用单位自查还应当包括使用过程是否符合操作规范和产品说明书要求等。必要时,医疗器械经营企业、使用单位应当暂停医疗器械的销售、使用,并协助相关单位采取相关控制措施。
Article 34 The drug administration of province, autonomous region, or municipality directly under the Central Government shall, after a group medical device adverse event that occurs within the administrative region comes its knowledge, conduct an on-site investigation with the health department at the same level in a timely manner, and the drug administrations of relevant provinces, autonomous regions and municipalities directly under the Central Government shall cooperate. The results of investigation, evaluation and disposition shall be reported to the State Drug Administration and the health department of the State Council in a timely manner, with the drug administration of the province, autonomous region, or municipality directly under the Central Government where the licensee is located copied in.   第三十四条 省、自治区、直辖市药品监督管理部门在获知本行政区域内发生的群体医疗器械不良事件后,应当会同同级卫生行政部门及时开展现场调查,相关省、自治区、直辖市药品监督管理部门应当配合。调查、评价和处理结果应当及时报国家药品监督管理局和国务院卫生行政部门,抄送持有人所在地省、自治区、直辖市药品监督管理部门。
Article 35 The State Drug Administration shall, in conjunction with the health department of the State Council, organize an investigation and disposition of group medical device adverse events that have a relatively large impact nationwide and cause serious impairment or death or any other serious consequences. The national monitoring agency shall be responsible for on-site investigations, and the drug administrations and health departments of relevant provinces, autonomous regions and municipalities directly under the Central Government shall cooperate.   第三十五条 对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,国家药品监督管理局应当会同国务院卫生行政部门组织调查和处理。国家监测机构负责现场调查,相关省、自治区、直辖市药品监督管理部门、卫生行政部门应当配合。
The investigation content shall include the occurrence of medical device adverse events, use of medical devices, diagnosis and treatment, previous similar adverse events, product's production process, product storage and circulation, and tracking of product of the same model and the same lot. 调查内容应当包括医疗器械不良事件发生情况、医疗器械使用情况、患者诊治情况、既往类似不良事件、产品生产过程、产品贮存流通情况以及同型号同批次产品追踪等。
Article 36 The national monitoring agency and the drug administrations and health departments of relevant provinces, autonomous regions and municipalities directly under the Central Government shall, within five days after an investigation is completed, conduct technical evaluation of product risk based on the investigation, propose control measures, prepare an investigation report, and report to the State Drug Administration and the health department of the State Council.   第三十六条 国家监测机构和相关省、自治区、直辖市药品监督管理部门、卫生行政部门应当在调查结束后5日内,根据调查情况对产品风险进行技术评价并提出控制措施建议,形成调查报告报国家药品监督管理局和国务院卫生行政部门。
Article 37 The drug administration of the province, autonomous region or municipality directly under the Central Government where the licensee is located may conduct on-site inspection of the licensee involved in a group adverse event. When necessary, the State Drug Administration may conduct an on-site inspection of the overseas licensee involved in a group adverse event.   第三十七条 持有人所在地省、自治区、直辖市药品监督管理部门可以对群体不良事件涉及的持有人开展现场检查。必要时,国家药品监督管理局可以对群体不良事件涉及的境外持有人开展现场检查。
The on-site inspection shall cover the operation of the production quality management system, the quality status of the product, the production process, and the tracking of product of the same model and the same lot. 现场检查应当包括生产质量管理体系运行情况、产品质量状况、生产过程、同型号同批次产品追踪等。
Section 4 Periodic Risk Assessment Reports 

第四节 定期风险评价报告

 
Article 38 A licensee shall conduct continuous research on the safety of marketed medical devices, gather and analyze the adverse event reports on the product, monitoring materials, and risk information at home and abroad, and evaluate the risk and benefits of the product, keep records of the risk control measures taken, and prepare a post-market periodic risk evaluation report.   第三十八条 持有人应当对上市医疗器械安全性进行持续研究,对产品的不良事件报告、监测资料和国内外风险信息进行汇总、分析,评价该产品的风险与受益,记录采取的风险控制措施,撰写上市后定期风险评价报告。
Article 39 A licensee shall complete the post-market periodic risk evaluation report on the product for the previous year within 60 days after the expiry of each year from the date of the first approval of product registration or filing. If the registration is made by the State Drug Administration, submission shall be made to the national monitoring agency; or, if the registration is made by the drug administration of the province, autonomous region or municipality directly under the Central Government, to the provincial monitoring agency in the place where the licensee is located. The periodic risk assessment reports on Class-I medical devices shall be retained by the licensee for inspection.   第三十九条 持有人应当自产品首次批准注册或者备案之日起,每满一年后的60日内完成上年度产品上市后定期风险评价报告。其中,经国家药品监督管理局注册的,应当提交至国家监测机构;经省、自治区、直辖市药品监督管理部门注册的,应当提交至所在地省级监测机构。第一类医疗器械的定期风险评价报告由持有人留存备查。
For medical devices of which the renewal of the registration has been granted, the periodic risk evaluation report for the current registration cycle shall be completed at the next application for renewal of registration and retained by the licensee for inspection. 获得延续注册的医疗器械,应当在下一次延续注册申请时完成本注册周期的定期风险评价报告,并由持有人留存备查。
Article 40 The monitoring agency at or above the provincial level shall organize the review of the post-market periodic risk assessment reports on medical device products received. If necessary, the licensee shall be provided with feedback on the review opinions.   第四十条 省级以上监测机构应当组织对收到的医疗器械产品上市后定期风险评价报告进行审核。必要时,应当将审核意见反馈持有人。
Article 41 A provincial monitoring agency shall comprehensively analyze post-market periodic risk evaluation reports received and submit the statistics for and analysis and evaluation results of the post-market periodic risk evaluation reports to the national monitoring agency and the drug administration of the province, autonomous region or municipality directly under the Central Government in the place before May 1 of each year.   第四十一条 省级监测机构应当对收到的上市后定期风险评价报告进行综合分析,于每年5月1日前将上一年度上市后定期风险评价报告统计情况和分析评价结果报国家监测机构和所在地省、自治区、直辖市药品监督管理部门。
The national monitoring agency shall conduct a comprehensive analysis of post-market periodic risk assessment reports received and the statistics for and analysis and evaluation results of reports submitted by provincial monitoring agencies and submit the statistics for and analysis and evaluation results of post-market periodic risk evaluation reports for the previous year to the State Drug Administration before July 1 of each year. 国家监测机构应当对收到的上市后定期风险评价报告和省级监测机构提交的报告统计情况及分析评价结果进行综合分析,于每年7月1日前将上一年度上市后定期风险评价报告统计情况和分析评价结果报国家药品监督管理局。
Chapter IV Priority Monitoring 

第四章 重点监测

 
Article 42 The drug administrations at or above the provincial level may organize and conduct priority monitoring of medical devices and strengthen post-market risk research on medical device products.   第四十二条 省级以上药品监督管理部门可以组织开展医疗器械重点监测,强化医疗器械产品上市后风险研究。
Article 43 The State Drug Administration and the health department of the State Council shall determine the types of medical devices subject to priority monitoring, organize the formulation of a work plan for priority monitoring, and supervise the implementation.   第四十三条 国家药品监督管理局会同国务院卫生行政部门确定医疗器械重点监测品种,组织制定重点监测工作方案,并监督实施。
The national types of medical devices subject to priority monitoring shall be determined according to medical device registration, adverse event monitoring, supervisory inspection, inspection, and other information, taking account the risk degree and use status of the product. 国家医疗器械重点监测品种应当根据医疗器械注册、不良事件监测、监督检查、检验等情况,结合产品风险程度和使用情况确定。
The national monitoring agency shall organize the implementation of priority monitoring of medical devices and complete relevant technical reports. The drug administration may take necessary administrative measures based on the risk discovered during the monitoring. 国家监测机构组织实施医疗器械重点监测工作,并完成相关技术报告。药品监督管理部门可根据监测中发现的风险采取必要的管理措施。
Article 44 The drug administration of a province, autonomous region or municipality directly under the Central Government may, as needed for the regulation of medical devices within its administrative region, according to the provisions of Article 43 of these Measures mutatis mutandis, conduct provincial medical device priority monitoring with respect to Class-II medical devices registered and Class-I ones filed in the administrative region.   第四十四条 省、自治区、直辖市药品监督管理部门可以根据本行政区域内医疗器械监管工作需要,参照本办法第四十三条规定,对本行政区内注册的第二类和备案的第一类医疗器械开展省级医疗器械重点监测工作。
Article 45 A licensee involved in the types of medical devices subject to priority monitoring shall conduct work as required in the work plan for priority monitoring of medical devices, actively collect relevant risk information such as adverse event reports on its products, prepare a risk evaluation report, and submit it to the priority monitoring organization department as required.   第四十五条 医疗器械重点监测品种涉及的持有人应当按照医疗器械重点监测工作方案的要求开展工作,主动收集其产品的不良事件报告等相关风险信息,撰写风险评价报告,并按要求报送至重点监测工作组织部门。
Article 46 Drug administrations at or above the provincial level may designate entities with certain conditions as monitoring stations and actively collect priority monitoring data. The monitoring stations shall provide information on the use of types of medical devices subject to priority monitoring, actively collect and report adverse event monitoring information, arrange for relevant experts to carry out or cooperate with monitoring agencies in carrying out scientific research related to risk evaluation, or recommend relevant experts to that effect.   第四十六条 省级以上药品监督管理部门可以指定具备一定条件的单位作为监测哨点,主动收集重点监测数据。监测哨点应当提供医疗器械重点监测品种的使用情况,主动收集、报告不良事件监测信息,组织或者推荐相关专家开展或者配合监测机构开展与风险评价相关的科学研究工作。
Article 47 An innovative medical device licensee shall strengthen the proactive monitoring of innovative medical devices, formulate a product monitoring plan, actively collect relevant adverse event reports and product complaint information, and conduct investigations, analysis and evaluation.   第四十七条 创新医疗器械持有人应当加强对创新医疗器械的主动监测,制定产品监测计划,主动收集相关不良事件报告和产品投诉信息,并开展调查、分析、评价。
An innovative medical device licensee shall submit a consolidated report on monitoring, analysis and evaluation of product adverse events to the national monitoring agency every half a year during the first registration cycle. If the national monitoring agency discovers information that there may be a serious defect in medical devices, it shall report to the State Drug Administration in a timely manner. 创新医疗器械持有人应当在首个注册周期内,每半年向国家监测机构提交产品不良事件监测分析评价汇总报告。国家监测机构发现医疗器械可能存在严重缺陷的信息,应当及时报国家药品监督管理局。
Chapter V Risk Control 

第五章 风险控制

 
Article 48 Where a licensee discovers through the monitoring of medical device adverse events that there are medical devices containing unreasonable risk which may endanger human health and life safety, it shall take the following risk control measures according to the circumstances and report to the drug administration of the province, autonomous region, or municipality directly under the Central Government where it is located:   第四十八条 持有人通过医疗器械不良事件监测,发现存在可能危及人体健康和生命安全的不合理风险的医疗器械,应当根据情况采取以下风险控制措施,并报告所在地省、自治区、直辖市药品监督管理部门:
(1) Ceasing production or sale of related products. (一)停止生产、销售相关产品;
(2) Notifying medical device operation enterprises and user entities of suspending sale or use. (二)通知医疗器械经营企业、使用单位暂停销售和使用;
(3) Implementing a product recall. (三)实施产品召回;
(4) Releasing risk information. (四)发布风险信息;
(5) Conducting self-inspection of the production quality management system and rectifying related issues. (五)对生产质量管理体系进行自查,并对相关问题进行整改;
(6) Amending the instruction manual, label, and operating manual, among others. (六)修改说明书、标签、操作手册等;
(7) Improving production process, design, and product's technical requirements, among others. (七)改进生产工艺、设计、产品技术要求等;
(8) Carrying out re-evaluation of medical devices. (八)开展医疗器械再评价;
(9) Having registration or filing modified as required. (九)按规定进行变更注册或者备案;
(10) Other risk control measures that need taking. (十)其他需要采取的风险控制措施。
The licensee shall promptly release the information on risk and disposition related to the use safety of medical devices. 与用械安全相关的风险及处置情况,持有人应当及时向社会公布。
Article 49 Where the drug administration considers that the control measures taken by the licensee are insufficient to effectively prevent risk, it may take measures, such as issuing warning information, suspending production, sale and use, ordering a recall, requiring the licensee to amend the instruction manual and label, and organizing and conducting re-evaluation, and organize and conduct supervisory inspection of the licensee.   第四十九条 药品监督管理部门认为持有人采取的控制措施不足以有效防范风险的,可以采取发布警示信息、暂停生产销售和使用、责令召回、要求其修改说明书和标签、组织开展再评价等措施,并组织对持有人开展监督检查。
Article 50 For medical devices relating to which a group medical device adverse event occurs, the drug administration at or above the provincial level may, according to the risk situation, take control measures such as suspension of production, sale and use, organize supervisory inspection of the licensee, and promptly release warning and disposition information. After coming to a technical evaluation conclusion, the drug administration at or above the provincial level shall, as required by relevant laws and regulations, take further regulatory measures and strengthen the monitoring of adverse events relating to similar medical devices.   第五十条 对发生群体医疗器械不良事件的医疗器械,省级以上药品监督管理部门可以根据风险情况,采取暂停生产、销售、使用等控制措施,组织对持有人开展监督检查,并及时向社会发布警示和处置信息。在技术评价结论得出后,省级以上药品监督管理部门应当根据相关法规要求,采取进一步监管措施,并加强对同类医疗器械的不良事件监测。
The health department at the same level shall have the use of relevant medical devices by medical institutions suspended within its administrative region and take measures to actively organize the treatment of patients. The relevant licensee shall cooperate. 同级卫生行政部门应当在本行政区域内暂停医疗机构使用相关医疗器械,采取措施积极组织救治患者。相关持有人应当予以配合。
Article 51 Where a monitoring agency at or above the provincial level discovers unreasonable risk for medical devices in evaluation and review of medical device adverse event reports, consolidated analysis of quarterly and annual adverse event reports, evaluation of group adverse events, priority monitoring, periodic risk evaluation reporting, and other process, it shall put forward a risk management opinion, promptly provide feedback for the licensee, and report to the corresponding drug administration. A provincial monitoring agency shall also report to the national monitoring agency.   第五十一条 省级以上监测机构在医疗器械不良事件报告评价和审核、不良事件报告季度和年度汇总分析、群体不良事件评价、重点监测、定期风险评价报告等过程中,发现医疗器械存在不合理风险的,应当提出风险管理意见,及时反馈持有人并报告相应的药品监督管理部门。省级监测机构还应当向国家监测机构报告。
The licensee shall formulate and implement corresponding risk control measures based on the risk management opinion received. 持有人应当根据收到的风险管理意见制定并实施相应的风险控制措施。
Article 52 The drug administrations and the health departments at all levels may commission medical device inspection institutions with corresponding qualifications to inspect the products involved in medical device adverse events when necessary. The medical device inspection institutions shall promptly carry out relevant inspection and issue inspection reports.   第五十二条 各级药品监督管理部门和卫生行政部门必要时可以将医疗器械不良事件所涉及的产品委托具有相应资质的医疗器械检验机构进行检验。医疗器械检验机构应当及时开展相关检验,并出具检验报告。
Article 53 Where medical devices, either imported or domestically produced, in relation to which a medical device adverse event occurs overseas, are subjected to control measures, the agent designated by the overseas licensee or the domestically produced medical device licensee shall, within 24 hours after becoming aware, report the information on the overseas medical device adverse event, the control measures, and control measures to be taken in China to the State Drug Administration and the national monitoring agency, copy in the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, and report subsequent disposition in a timely manner.   第五十三条 进口医疗器械在境外发生医疗器械不良事件,或者国产医疗器械在境外发生医疗器械不良事件,被采取控制措施的,境外持有人指定的代理人或者国产医疗器械持有人应当在获知后24小时内,将境外医疗器械不良事件情况、控制措施情况和在境内拟采取的控制措施报国家药品监督管理局和国家监测机构,抄送所在地省、自治区、直辖市药品监督管理部门,及时报告后续处置情况。
Article 54 Where a suspected medical device adverse event results from the quality of medical device product, the drug administration shall dispose in accordance with the regulations relating to medical devices; and if it results from the use of the medical device, the health department shall dispose.   第五十四条 可疑医疗器械不良事件由医疗器械产品质量原因造成的,由药品监督管理部门按照医疗器械相关法规予以处置;由医疗器械使用行为造成的,由卫生行政部门予以处置。
Chapter VI Re-evaluation 

第六章 再评价

 
Article 55 Under any of the following circumstances, a licensee shall take the initiative to carry out re-evaluation and take corresponding measures according to the re-evaluation conclusion:   第五十五条 有下列情形之一的,持有人应当主动开展再评价,并依据再评价结论,采取相应措施:
(1) As a result of the development of scientific research, the understanding of the safety and effect of medical devices changes. (一)根据科学研究的发展,对医疗器械的安全、有效有认识上改变的;
(2) The results of monitoring and evaluation of medical device adverse events show that the medical devices may have defects. (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的;
(3) The State Drug Administration otherwise provides that re-evaluation shall be carried out. (三)国家药品监督管理局规定应当开展再评价的其他情形。
Article 56 A licensee shall, when conducting re-evaluation of medical devices, re-evaluate the summary materials in the original medical device registration materials, research materials, clinical evaluation materials, product risk analysis materials, product's technical requirements, instruction manual, labels, and other technical data and content, according to the product safety and effect information, clinical data, and use experience known or gained after the product is marketed.   第五十六条 持有人开展医疗器械再评价,应当根据产品上市后获知和掌握的产品安全有效信息、临床数据和使用经验等,对原医疗器械注册资料中的综述资料、研究资料、临床评价资料、产品风险分析资料、产品技术要求、说明书、标签等技术数据和内容进行重新评价。
Article 57 A re-evaluation report shall include product risk and benefit assessment, socio-economic benefit assessment, technical progress assessment, and measures and recommendations to be taken.   第五十七条 再评价报告应当包括产品风险受益评估、社会经济效益评估、技术进展评估、拟采取的措施建议等。
Article 58 Where a licensee voluntarily re-evaluates medical devices, it shall formulate a re-evaluation work plan. If it is determined through the re-evaluation that it is necessary to take control measures, a re-evaluation report shall be submitted within 15 days after the re-evaluation conclusion is reached. For medical devices whose registration or filing is approved by the State Drug Administration, the licensee shall make submission to the national monitoring agency; and the licensee of other medical devices shall make submission to the provincial monitoring agency in the place where it is located.   第五十八条 持有人主动开展医疗器械再评价的,应当制定再评价工作方案。通过再评价确定需要采取控制措施的,应当在再评价结论形成后15日内,提交再评价报告。其中,国家药品监督管理局批准注册或者备案的医疗器械,持有人应当向国家监测机构提交;其他医疗器械的持有人应当向所在地省级监测机构提交。
If a licensee fails to fulfill its medical device re-evaluation obligation as required, the drug administration at or above the provincial level shall order the licensee to carry out the re-evaluation. When necessary, the drug administrations at or above the provincial level may directly organize and conduct re-evaluation. 持有人未按规定履行医疗器械再评价义务的,省级以上药品监督管理部门应当责令持有人开展再评价。必要时,省级以上药品监督管理部门可以直接组织开展再评价。
Article 59 Where the drug administration at or above the provincial level orders re-evaluation, the licensee shall submit a re-evaluation proposal to the corresponding drug administration and the monitoring agency within 30 days before the re-evaluation is implemented and submit a re-evaluation report to the same within 30 days after the re-evaluation is completed.   第五十九条 省级以上药品监督管理部门责令开展再评价的,持有人应当在再评价实施前和再评价结束后30日内向相应药品监督管理部门及监测机构提交再评价方案和再评价报告。
If the implementation period for evaluation exceeds one year, the licensee shall report the annual progress each year. 再评价实施期限超过1年的,持有人应当每年报告年度进展情况。
Article 60 Monitoring agencies shall review the re-evaluation reports received from licensees and report the review opinions to corresponding drug administrations.   第六十条 监测机构对收到的持有人再评价报告进行审核,并将审核意见报相应的药品监督管理部门。
If the drug administration disagrees with the conclusion of the re-evaluation carried out by the licensee, the licensee shall re-confirm the re-evaluation results or conduct another re-evaluation as required by the drug administration. 药品监督管理部门对持有人开展的再评价结论有异议的,持有人应当按照药品监督管理部门的要求重新确认再评价结果或者重新开展再评价。
Article 61 Where the drug administration organizes and conducts re-evaluation of medical devices, the designated monitoring agency shall formulate a re-evaluation plan, organize and implement it with the approval of the drug administration that organizes and conducts the re-evaluation, prepare a re-evaluation report, and report to the corresponding drug administration.   第六十一条 药品监督管理部门组织开展医疗器械再评价的,由指定的监测机构制定再评价方案,经组织开展再评价的药品监督管理部门批准后组织实施,形成再评价报告后向相应药品监督管理部门报告。
Article 62 Where re-evaluation results show that the registered or filed medical devices have a defect that endangers personal safety, and it is impossible to eliminate or control the risk through technical improvement, amendment of the instruction manual or labels, or other measures, or the risk-to-benefit ratio is unacceptable, the licensee shall voluntarily apply for cancellation of the medical device registration certificate or the product filing; and if the licensee fails to do so, the original issuing department shall cancel the medical device registration certificate or the filing. The drug administration shall promptly release the information relating to the cancellation of the medical device registration certificate or the filing.   第六十二条 再评价结果表明已注册或者备案的医疗器械存在危及人身安全的缺陷,且无法通过技术改进、修改说明书和标签等措施消除或者控制风险,或者风险获益比不可接受的,持有人应当主动申请注销医疗器械注册证或者取消产品备案;持有人未申请注销医疗器械注册证或者取消备案的,由原发证部门注销医疗器械注册证或者取消备案。药品监督管理部门应当将注销医疗器械注册证或者取消备案的相关信息及时向社会公布。
The State Drug Administration may decide in favor of the elimination of medical device varieties according to the re-evaluation conclusion. For the product eliminated, the medical device registration certificate or product filing shall be canceled by the original issuing department. 国家药品监督管理局根据再评价结论,可以对医疗器械品种作出淘汰的决定。被淘汰的产品,其医疗器械注册证或者产品备案由原发证部门予以注销或者取消。
Medical devices in relation to which medical device registration certificate or filing has been canceled may not be produced, imported, operated, or used. 被注销医疗器械注册证或者被取消备案的医疗器械不得生产、进口、经营和使用。
Chapter VII Supervision and Administration 

第七章 监督管理

 
Article 63 Drug administrations shall supervise and inspect the adverse event monitoring and re-evaluation of medical devices by licensees and operation enterprises in accordance with their duties and, in conjunction with the health departments at the same level, supervise and inspect the monitoring of medical device adverse events by medical device user entities.   第六十三条 药品监督管理部门应当依据职责对持有人和经营企业开展医疗器械不良事件监测和再评价工作情况进行监督检查,会同同级卫生行政部门对医疗器械使用单位开展医疗器械不良事件监测情况进行监督检查。
Article 64 The drug administration of a province, autonomous region or municipality directly under the Central Government shall formulate a supervision and inspection plan for the monitoring of medical device adverse events in its administrative region, determine its inspection focus, and supervise its implementation.   第六十四条 省、自治区、直辖市药品监督管理部门应当制定本行政区域的医疗器械不良事件监测监督检查计划,确定检查重点,并监督实施。
Article 65 The drug administration of a province, autonomous region or municipality directly under the Central Government shall strengthen the training and evaluation of staff engaging in the monitoring and re-evaluation of medical device adverse events in its administrative region.   第六十五条 省、自治区、直辖市药品监督管理部门应当加强对本行政区域内从事医疗器械不良事件监测和再评价工作人员的培训和考核。
Article 66 Drug administrations shall, in accordance with the requirements of laws, regulations, rules, and standards, supervise and inspect licensees' development of adverse event monitoring systems and work conducting. If necessary, an extension inspection may be conducted for enterprises commissioned by a licensee to carry out related work.   第六十六条 药品监督管理部门应当按照法规、规章、规范的要求,对持有人不良事件监测制度建设和工作开展情况实施监督检查。必要时,可以对受持有人委托开展相关工作的企业开展延伸检查。
Article 67 Under any of the following circumstances, the drug administration shall carry out a priority inspection of a licensee:   第六十七条 有下列情形之一的,药品监督管理部门应当对持有人开展重点检查:
(1) Failing to proactively collect and, according to time limit requirements, report a medical device adverse event. (一)未主动收集并按照时限要求报告医疗器械不良事件的;
(2) The number of reports on adverse events that result or may result in serious impairment or death submitted by the licensee is quite different from that of reports from medical institutions, and it is reminded that its primary responsibility is not effectively implemented. (二)持有人上报导致或可能导致严重伤害或者死亡不良事件的报告数量与医疗机构的报告数量差距较大,提示其主体责任未落实到位的;
(3) Conducting concealment, having an omission, or making a false statement in a report. (三)瞒报、漏报、虚假报告的;
(4) Failing to cooperate with the drug administration in the investigation relating to medical device adverse events and the control measures taken. (四)不配合药品监督管理部门开展的医疗器械不良事件相关调查和采取的控制措施的;
(5) Failing to collect product safety information through adverse event monitoring as required, or failing to conduct post-market research or re-evaluation as required, or unable to guarantee the safety and effect of product. (五)未按照要求通过不良事件监测收集产品安全性信息,或者未按照要求开展上市后研究、再评价,无法保证产品安全有效的。
Article 68 Where a licensee fails to establish an adverse event monitoring system as required, carry out the work relating to adverse event monitoring and re-evaluation, take effective risk control measures promptly according to Article 48 of these Measures, or cooperate with the drug administration in the investigation relating to medical device adverse events and control measures taken, the drug administration may require it to suspend production for rectification and, if necessary, take control measures to cease product sale.   第六十八条 持有人未按照要求建立不良事件监测制度、开展不良事件监测和再评价相关工作、未按照本办法第四十八条规定及时采取有效风险控制措施、不配合药品监督管理部门开展的医疗器械不良事件相关调查和采取的控制措施的,药品监督管理部门可以要求其停产整改,必要时采取停止产品销售的控制措施。
If it is necessary to resume production or sale, the licensee shall submit an application to the drug administration that has made the disposition decision, and after the on-site inspection is passed, the drug administration shall decide in favor of resumption of production or sale. 需要恢复生产、销售的,持有人应当向作出处理决定的药品监督管理部门提出申请,药品监督管理部门现场检查通过后,作出恢复生产、销售的决定。
The licensee may, before applying for resuming production or sale, engage an independent third-party professional organization with corresponding qualifications to conduct inspection and confirmation. 持有人提出恢复生产、销售申请前,可以聘请具备相应资质的独立第三方专业机构进行检查确认。
Article 69 The drug administrations at or above the provincial level shall publish the following information on monitoring of medical device adverse events in a unified manner:   第六十九条 省级以上药品监督管理部门统一发布下列医疗器械不良事件监测信息:
(1) Information on group medical device adverse events. (一)群体医疗器械不良事件相关信息;
(2) Information on monitoring and warning of medical device adverse events. (二)医疗器械不良事件监测警示信息;
(3) Information on the monitoring of medical device adverse events that need releasing regularly. (三)需要定期发布的医疗器械不良事件监测信息;
(4) Other information on medical device adverse events which it is considered to be necessary to release in a unified manner. (四)认为需要统一发布的其他医疗器械不良事件监测信息。
Chapter VIII Legal Liability 

第八章 法律责任

 
Article 70 Where a licensee has one of the following circumstances, the drug administration at or above the county level shall, in accordance with the provisions of Article 68 of the Regulation on the Supervision and Administration of Medical Devices, order it to take corrective action and give a warning; and shall impose a fine of not less than 5,000 yuan nor more than 20,000 yuan if it refuses to do so; or if the circumstances are serious, shall order suspension of its production or business, or the issuing department shall suspend relevant evidential documents:   第七十条 持有人有下列情形之一的,依照《医疗器械监督管理条例》第六十八条的规定,由县级以上药品监督管理部门责令改正,给予警告;拒不改正的,处5000元以上2万元以下罚款;情节严重的,责令停产停业,直至由发证部门吊销相关证明文件:
(1) Failing to proactively collect and, according to time limit requirements, report a medical device adverse event. (一)未主动收集并按照时限要求报告医疗器械不良事件的;
(2) Conducting concealment, having an omission, or making a false statement in a report. (二)瞒报、漏报、虚假报告的;
(3) Failing to report evaluation results according to time limit requirements or submit a group medical device adverse event investigation report. (三)未按照时限要求报告评价结果或者提交群体医疗器械不良事件调查报告的;
(4) Failing to cooperate in the investigation relating to medical device adverse events conducted and control measures taken by the drug administration and the monitoring agency. (四)不配合药品监督管理部门和监测机构开展的医疗器械不良事件相关调查和采取的控制措施的。
Article 71 Where a medical device operation enterprise or user entity has one of the following circumstances, the drug administration and the health department at or above the county level shall, in accordance with the provisions of Article 68 of the Regulation on the Supervision and Administration of Medical Devices, based on their respective duties, order it to take corrective action and give a warning; and shall impose a fine of not less than 5,000 yuan nor more than 20,000 yuan if it refuses to do so; or if the circumstances are serious, shall order suspension of its production or business, or the issuing department shall suspend relevant evidential documents:   第七十一条 医疗器械经营企业、使用单位有下列情形之一的,依照《医疗器械监督管理条例》第六十八条的规定,由县级以上药品监督管理部门和卫生行政部门依据各自职责责令改正,给予警告;拒不改正的,处5000元以上2万元以下罚款;情节严重的,责令停产停业,直至由发证部门吊销相关证明文件:
(1) Failing to proactively collect and, according to time limit requirements, report a medical device adverse event. (一)未主动收集并按照时限要求报告医疗器械不良事件的;
(2) Conducting concealment, having an omission, or making a false statement in a report. (二)瞒报、漏报、虚假报告的;
(3) Failing to cooperate in the investigation relating to medical device adverse events conducted and control measures taken by the drug administration and the monitoring agency. (三)不配合药品监督管理部门和监测机构开展的医疗器械不良事件相关调查和采取的控制措施的。
Article 72 Where a licensee fails to carry out re-evaluation as required, conceals re-evaluation results, or fails to file an application for cancellation of registration as required, the drug administration at or above the provincial level shall order it to take corrective action and give a warning, and may, in addition, impose a fine of not less than 10,000 yuan nor more than 30,000 yuan.   第七十二条 持有人未按照要求开展再评价、隐匿再评价结果、应当提出注销申请而未提出的,由省级以上药品监督管理部门责令改正,给予警告,可以并处1万元以上3万元以下罚款。
Article 73 Where a licensee has one of the following circumstances, the drug administration at or above the county level shall order it to take corrective action and give a warning; and shall impose a fine of not less than 5,000 yuan nor more than 20,000 yuan if it refuses to do so:   第七十三条 持有人有下列情形之一的,由县级以上药品监督管理部门责令改正,给予警告;拒不改正的,处5000元以上2万元以下罚款:
(1) Failing to establish working rules for adverse event monitoring and re-evaluation of medical devices as required. (一)未按照规定建立医疗器械不良事件监测和再评价工作制度的;
(2) Failing, as required, to assign institutions and personnel commensurate with their products to engage in the work relating to the monitoring of medical device adverse events. (二)未按照要求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的;
(3) Failing to keep monitoring records of medical device adverse events, or failing to keep them for the required period. (三)未保存不良事件监测记录或者保存年限不足的;
(4) Failing to be registered as a user of the National Medical Device Adverse Event Monitoring Information System as required. (四)应当注册而未注册为医疗器械不良事件监测信息系统用户的;
(5) Failing to voluntarily maintain user information, or continuously track and process monitoring information. (五)未主动维护用户信息,或者未持续跟踪和处理监测信息的;
(6) Failing to take corresponding control measures according to the adverse event and release them. (六)未根据不良事件情况采取相应控制措施并向社会公布的;
(7) Failing to prepare, submit or retain a post-market periodic risk evaluation report as required. (七)未按照要求撰写、提交或者留存上市后定期风险评价报告的;
(8) Failing to report an overseas medical device adverse event and overseas control measures as required. (八)未按照要求报告境外医疗器械不良事件和境外控制措施的;
(9) Failing to submit a consolidated report on the analysis and evaluation of innovative medical device products as required. (九)未按照要求提交创新医疗器械产品分析评价汇总报告的;
(10) Failing to release contact information or proactively collect information on adverse events. (十)未公布联系方式、主动收集不良事件信息的;
(11) Failing to carry out priority monitoring of medical devices as required. (十一)未按照要求开展医疗器械重点监测的;
(12) Otherwise violating the provisions of these Measures. (十二)其他违反本办法规定的。
Article 74 Where a medical device operation enterprise or user entity has one of the following circumstances, the drug administration and the health department at or above the county level shall, based on their respective duties, order it to take corrective action and give a warning; and shall impose a fine of not less than 5,000 yuan nor more than 20,000 yuan if it refuses to do so:   第七十四条 医疗器械经营企业、使用单位有下列情形之一的,由县级以上药品监督管理部门和卫生行政部门依据各自职责责令改正,给予警告;拒不改正的,处5000元以上2万元以下罚款:
(1) Failing to establish working rules for monitoring of medical device adverse events as required. (一)未按照要求建立医疗器械不良事件监测工作制度的;
(2) Failing, as required, to assign 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)未按照要求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的;
(3) Failing to keep monitoring records of medical device adverse events, or failing to keep them for the required period. (三)未保存不良事件监测记录或者保存年限不足的;
(4) Failing to be registered as a user of the National Medical Device Adverse Event Monitoring Information System as required. (四)应当注册而未注册为国家医疗器械不良事件监测信息系统用户的;
(5) Failing to report to the licensee in a timely manner on the medical device adverse events collected or known. (五)未及时向持有人报告所收集或者获知的医疗器械不良事件的;
(6) Failing to cooperate with the licensee in investigating and evaluating a medical device adverse event. (六)未配合持有人对医疗器械不良事件调查和评价的;
(7) Otherwise violating the provisions of these Measures. (七)其他违反本办法规定的。
If the drug administration finds that a user entity commits the conduct as provided for in the preceding paragraph, it shall make a referral to the health department at the same level for disposition. 药品监督管理部门发现使用单位有前款规定行为的,应当移交同级卫生行政部门处理。
If the health department decides in favor of administrative punishment of the user entity, it shall promptly notify the drug administration at the same level. 卫生行政部门对使用单位作出行政处罚决定的,应当及时通报同级药品监督管理部门。
Article 75 Where a licensee, operation enterprise, or user entity reports, investigates, evaluates, or disposes of a medical device adverse event as required by these Measures and voluntarily eliminates or mitigates the harmful consequences, lesser or mitigated punishment shall be imposed in accordance with the provisions of the Administrative Punishment Law of the People's Republic Of China, for its relevant illegal conduct. If the illegal conduct is minor and promptly corrected, resulting in no harmful consequences, no punishment shall be imposed, but it shall not be exempt from other legal liability that it shall assume according to the law.   第七十五条 持有人、经营企业、使用单位按照本办法要求报告、调查、评价、处置医疗器械不良事件,主动消除或者减轻危害后果的,对其相关违法行为,依照《中华人民共和国行政处罚法》的规定从轻或者减轻处罚。违法行为轻微并及时纠正,没有造成危害后果的,不予处罚,但不免除其依法应当承担的其他法律责任。
Article 76 The drug administration, health department, or monitoring agency at each level or a staff member thereof that fails to perform duties as required shall be punished in accordance with Articles 72 and 74 of the Regulation on the Supervision and Administration of Medical Devices.   第七十六条 各级药品监督管理部门、卫生行政部门、监测机构及其工作人员,不按规定履行职责的,依照《医疗器械监督管理条例》第七十二条和第七十四条的规定予以处理。
Article 77 Where a licensee, operation enterprise, or user entity violates relevant regulations and causes damage to a medical device user, it shall be liable for compensation according to the law.   第七十七条 持有人、经营企业、使用单位违反相关规定,给医疗器械使用者造成损害的,依法承担赔偿责任。
Chapter IX Supplemental Provisions 

第九章 附 则

 
Article 78 The contents of medical device adverse event reports, risk analysis and evaluation reports, and statistical materials shall be the basis for strengthening the supervision and administration of medical devices and guiding the reasonable use of medical devices, instead of that for medical disputes, action of medical care, and handling medical device quality accidents.   第七十八条 医疗器械不良事件报告的内容、风险分析评价报告和统计资料等是加强医疗器械监督管理、指导合理用械的依据,不作为医疗纠纷、医疗诉讼和处理医疗器械质量事故的依据。
Medical accidents or medical device quality problems shall be handled separately as required by relevant laws and regulations. 对于属于医疗事故或者医疗器械质量问题的,应当按照相关法规的要求另行处理。
Article 79 These Measures shall be subject to the interpretation of the State Drug Administration in conjunction with the health department of the State Council.   第七十九条 本办法由国家药品监督管理局会同国务院卫生行政部门负责解释。
Article 80 These Measures shall come into force on January 1, 2019.   第八十条 本办法自2019年1月1日起施行。
     
     
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