| 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。
．．．．．． |
|
Dear visitor, as a premium member of this database, you will get complete access to all content.Please go premium and get more.
1. To become a premium member, please call 400-810-8266 Ext. 171.
2. Binding to the account with access to this database.
3. Apply for a trial account.
4. To get instant access to a document, you can Pay Amount 【￥1400.00】 for your single purchase. | |
您好：您现在要进入的是北大法宝英文库会员专区。
如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户；您可通过网上支付进行单篇购买，支付成功后即可立即查看本篇内容。
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail:info@chinalawinfo.com
|
| | | |
| | | |