医疗器械不良事件监测和再评价_英文

《医疗器械不良事件监测和再评价管理办法》（国家市场监督管理总局令第1号）

Measures for the Management of the Monitoring and Reevaluation of

Medical Device Adverse Events

(Decree No.1 by State Administration for Market Regulation)

2018年08月31日 发布

Released on August 31, 2018

《医疗器械不良事件监测和再评价管理办法》已经国家市场监督管理总局和国家卫生健康委员会审议通过，现予公布，自2019年1月1日起施行。

Measures for the Management of the Monitoring and Reevaluation of Medical Device Adverse Events has been

reviewed and approved by State Administration for Market Regulation and National Health Commision, and now

is promulgated and effective as of January 1, 2019.

国家市场监督管理总局局长：张茅

Director General of State Administration for Market Regulation: Zhangmao

国家卫生健康委员会主任：马晓伟

Director of National Health Commision: Ma Xiaowei

2018年8月13日

August 13, 2018

医疗器械不良事件监测和再评价管理办法

Measures for the Management of the Monitoring and Reevaluation of Medical Device

Adverse Events

第一章 总 则

Chapter I General Provisions

第一条 为加强医疗器械不良事件监测和再评价，及时、有效控制医疗器械上市后风险，保障人体健康和生命安全，根据《医疗器械监督管理条例》，制定本办法。

Article 1 In order to strengthen the monitoring and reevaluation of medical device adverse events, timely and

effectively control the risks of post-market medical devices, and guarantee human health and life safety, the

Measures for the Management of the Monitoring and Reevaluation of Medical Device Adverse Events (hereinafter

referred to as “the Measures”) is formulated in accordance with the Regulations for the Supervision and

Administration of Medical Devices.

第二条 在中华人民共和国境内开展医疗器械不良事件监测、再评价及其监督管理，适用本办法。

Article 2 The Measures shall apply to the monitoring, reevaluation and supervision and management of medical

device adverse events carried out within the People’s Republic of China.

第三条 医疗器械上市许可持有人（以下简称持有人），应当具有保证医疗器械安全有效的质量管理能力和相应责任能力，建立医疗器械不良事件监测体系，向医疗器械不良事件监测技术机构（以下简称监测机构）直接报告医疗器械不良事件。由持有人授权销售的经营企业、医疗器械使用单位应当向持有人和监测机构报告医疗器械不良事件。

Article 3 Medical device listing approval holder (hereinafter referred to as the holder), shall have the quality

management capability and the corresponding responsibility capability to ensure the safety and effectiveness of

medical devices, establish medical device adverse event monitoring system, and directly report adverse events of

medical devices to the technical institution for the monitoring of adverse events of medical devices (hereinafter

referred to as “the monitoring institution”). The operating enterprise authorized by the holder to sell medical devices

and the medical device using unit shall report medical device adverse events to the holder and the monitoring

institution.

持有人应当对发现的不良事件进行评价，根据评价结果完善产品质量，并向监测机构报告评价结果和完善质量的措施；需要原注册机关审批的，应当按规定提交申请。

The holder shall evaluate the adverse events found, improve the product quality according to the evaluation results,

and report the evaluation results and measures for improving the quality to the monitoring institutions; if approval

from the original registration authority is required, the application for approval shall be submitted according to

relevant regulations.

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，配合持有人履行再评价义务。

The agent designated by the overseas holder shall undertake the monitoring of the adverse events of imported

medical devices sold within PRC and cooperate with the overseas holder to fulfill the obligation for reevaluation.

第四条 本办法下列用语的含义：

Article 4 The terms referred in the Measures shall have the following meanings:

（一）医疗器械上市许可持有人，是指医疗器械注册证书和医疗器械备案凭证的持有人，即医疗器械注册人和备案人。

(I) Medical device listing approval holder refers to the holder of registration certificate for medical device and

filing certificate for medical device, i.e., the registrant and filer of medical device.

（二）医疗器械不良事件，是指已上市的医疗器械，在正常使用情况下发生的，导致或者可能导致人体伤害的各种有害事件。

(II) Medical device adverse event refers to all kinds of harmful events of marketed medical devices that occur

under normal use of the medical devices and cause or possibly cause injury to human body.

（三）严重伤害，是指有下列情况之一者：

(III) Serious injury refers to any of the following circumstances:

1.危及生命；

1. Life-threatening;

2.导致机体功能的永久性伤害或者机体结构的永久性损伤；

2. Causing permanent injury to the functions of the body or permanent damage to the structure of the body;

3.必须采取医疗措施才能避免上述永久性伤害或者损伤。

3. Above permanent injury or damage which cannot be avoided until medical measures are taken.

（四）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，对一定数量人的身体健康或者生命安全造成损害或者威胁的事件。

(IV) Mass medical device adverse event refers to the event that occurs in a relatively concentrated time and area

during the use of the same medical device and causes damage or threat to the health or life safety of a certain number

of people.

（五）医疗器械不良事件监测，是指对医疗器械不良事件的收集、报告、调查、分析、评价和控制的过程。

(V) Monitoring of medical device adverse event refers to the process of collecting, reporting, investigation, analysis,

evaluation and control of medical device adverse events.

（六）医疗器械重点监测，是指为研究某一品种或者产品上市后风险情况、特征、严重程度、发生率等，主动开展的阶段性监测活动。

(VI) Intensive monitoring of medical device refers to the phased monitoring activities carried out with initiative to

study the post-market risks, characteristics, severity and incidence rate of a certain variety or product.

（七）医疗器械再评价，是指对已注册或者备案、上市销售的医疗器械的安全性、有效性进行重新评价，并采取相应措施的过程。

(VII) Medical device reevaluation refers to the process in which the safety and effectiveness of the medical

devices registered or filed or marketed are reevaluated and appropriate measures are taken.

第五条 国家药品监督管理局建立国家医疗器械不良事件监测信息系统，加强医疗器械不良事件监测信息网络和数据库建设。

Article 5 State Drug Administration (SDA) shall establish the national monitoring information system for adverse

events of medical devices and strengthen the construction of medical device adverse event monitoring information

network and database.

国家药品监督管理局指定的监测机构（以下简称国家监测机构）负责对收集到的医疗器械不良事件信息进行统一管理，并向相关监测机构、持有人、经营企业或者使用单位反馈医疗器械不良事件监测相关信息。

The monitoring institution designated by SDA (hereinafter referred to as “the national monitoring institution”) is

responsible for the unified management of the information concerning the medical device adverse event collected

and feedback the information relating to the monitoring of medical device adverse events back to relevant

monitoring institution, holder, operating enterprise or using unit.

与产品使用风险相关的监测信息应当向卫生行政部门通报。

The monitoring information related to the risk of product application shall be notified to the

health administrative

department.

第六条 省、自治区、直辖市药品监督管理部门应当建立医疗器械不良事件监测体系，完善相关制度，配备相应监测机构和人员，开展医疗器械不良事件监测工作。

Article 6 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the

central government shall establish a Medical Device Adverse Event Monitoring System, improve relevant rules and

regulations, assign corresponding monitoring institutions and personnel, and carry out monitoring of medical device

adverse events.

第七条 任何单位和个人发现医疗器械不良事件，有权向负责药品监督管理的部门（以下简称药品监督管理部门）或者监测机构报告。

Article 7 Any institution or individual that finds adverse events in medical devices shall have the right to report

them to the department in charge of drug supervision and administration (hereinafter referred to as the drug

regulatory authority) or the monito ring institution.

第二章 职责与义务

Chapter II Responsibilities and Obligations

第八条 国家药品监督管理局负责全国医疗器械不良事件监测和再评价的监督管理工作，会同国务院卫生行政部门组织开展全国范围内影响较大并造成严重伤害或者死亡以及其他严重后果的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 8 SDA shall be responsible for nationwide supervision and administration of monitoring and reevaluation

of adverse events of medical devices, working with health administrative department under the State Council to

organize and carry out investiagation and disposal of mass medical device adverse events that have a big impact

and cause serious injury or death and other serious consequences nationwide and take emergency control measures

in accordance with the relevant laws.

第九条 省、自治区、直辖市药品监督管理部门负责本行政区域内医疗器械不良事件监测和再评价的监督管理工作，会同同级卫生行政部门和相关部门组织开展本行政区域内发生的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 regulatory authorities of provinces, autonomous regions and municipalities directly under the

central government shall be responsible for the supervision and management on the monitoring and reevaluation of

medical device adverse events within respective administrative areas, and organize and conduct the investigation

and handling of mass medical device adverse event occurred within respective administrative areas in

conjunction with health administrative department and relevant department at the same level, and take emergency

control measures in accordance with law.

设区的市级和县级药品监督管理部门负责本行政区域内医疗器械不良事件监测相关工作。

Municipal and county-level drug regulatory authorities with districts shall be responsible for the monitoring of

medical device adverse events within their respective administrative areas.

第十条 上级药品监督管理部门指导和监督下级药品监督管理部门开展医疗器械不良事件监测和再评价的监督管理工作。

Article 10 The drug regulatory authority at a higher level shall guide and supervise the supervision and

management on the monitoring and reevaluation of medical device adverse events carried out by the drug regulatory

authority at a lower level.

第十一条 国务院卫生行政部门和地方各级卫生行政部门负责医疗器械使用单位中与医疗器械不良事件监测相关的监督管理工作，督促医疗器械使用单位开展医疗器械不良事件监测相关工作并组织检查，加强医疗器械不良事件监测工作的考核，在职责范围内依法对医疗器械不良事件采取相关控制措施。

Article 11 The health administrative department under the State Council and local of health administrative

departments at all levels shall be responsible for the supervision and management relating to the monitoring of

medical device adverse event in the using unit of medical devices, supervise and urge medical device using unit to

carry out the organizing and inspection on the monitoring of medical device adverse events, strengthen the

assessment of the monitoring of medical device adverse events, and take relevant control measures for medical

device adverse events according to law within the terms of reference.

上级卫生行政部门指导和监督下级卫生行政部门开展医疗器械不良事件监测相关的监督管理工作。

The health administrative department at a higher level shall guide and supervise the health administrative department

at a lower level to carry out supervision and management related to the monitoring of medical device adverse events.

第十二条 国家监测机构负责接收持有人、经营企业及使用单位等报告的医疗器械不良事件信息，承担全国医疗器械不良事件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体医疗器械不良事件的调查和评价。

Article 12 The national monitoring institution shall be responsible for receiving the information of medical

device adverse events reported by the holder, operating enterprise and using unit, and shall undertake the

technical work related to the monitoring and reevaluation of nationwide medical device adverse events; be

responsible for the construction, maintenance and information management of the national medical device adverse

event monitoring information network and database and to organize the formulation of technical specifications and

guiding principles, organize and carry out the investigation, evaluation and feedback of the information related to

adverse events of medical devices approved to register by SDA, summarize, analyze and guide the information of

adverse events of medical devices approved to register or file by the local drug regulatory authorities at or above

the municipal level, and carry out investigation and evaluation on mass medical device adverse events that have

great impact across country and have caused serious injury or death and other serious consequences.

第十三条 省、自治区、直辖市药品监督管理部门指定的监测机构（以下简称省级监测机构）组织开展本行政区域内医疗器械不良事件监测和再评价相关技术工作；承担本行政区域内注册或者备案的医疗器械不良事件的调查、评价和反馈，对本行政区域内发生的体医疗器械不良事件进行调查和评价。

Article 13 The monitoring institutions designated by the drug regulatory authorities of provinces, autonomous

regions and municipalities directly under the central government (hereinafter referred to as “the provincial

monitoring institutions”) shall organize the technical work related to the monitoring and reevaluation of adverse

events of medical devices within their respective administrative areas; undertake the investigation, evaluation and

feedback of the adverse events of the medical devices registered or recorded within the administrative area, and

investigate and evaluate mass medical device adverse events in the administrative area.

设区的市级和县级监测机构协助开展本行政区域内医疗器械不良事件监测相关技术工作。

Municipal and county-level monitoring institution with districts shall assist in the technical work related to the

monitoring of medical device adverse events within their respective administrative areas.

第十四条 持有人应当对其上市的医疗器械进行持续研究，评估风险情况，承担医疗器械不良事件监测的责任，根据分析评价结果采取有效控制措施，并履行下列主要义务：

Article 14 The holder shall conduct continuous research on its medical devices available on market, assess the

risks, assume the responsibility for monitoring adverse events of medical devices, take effective control measures

according to the analysis and evaluation results, and perform the following main obligations:

（一）建立包括医疗器械不良事件监测和再评价工作制度的医疗器械质量管理体系；

(I) Establish the quality management system for medical devices including the monitoring and reevaluation of

medical device adverse events;

（二）配备与其产品相适应的机构和人员从事医疗器械不良事件监测相关工作；

(II) Allocate the institutions and personnel appropriate to its products to engage in the monitoring of medical device

adverse events;

（三）主动收集并按照本办法规定的时限要求及时向监测机构如实报告医疗器械不良事件；

(III) Take the initiative to collect and truthfully report the adverse events of medical devices to the monitoring

institutions in a timely manner in accordance with the time limit stipulated in the Measures;

（四）对发生的医疗器械不良事件及时开展调查、分析、评价，采取措施控制风险，及时发布风险信息；

(IV) Carry out timely investigation, analysis and evaluation on the medical device adverse events occurred and take

measures to control risks and timely release risk information;

（五）对上市医疗器械安全性进行持续研究，按要求撰写定期风险评价报告；

(V) Conduct continuous research on the safety of the marketed medical devices and prepare periodic risk evaluation

reports as required;

（六）主动开展医疗器械再评价；

(VI) Conduct medical device reevaluation with initiative;

（七）配合药品监督管理部门和监测机构组织开展的不良事件调查。

(VII) Cooperate with drug regulatory authorities and monitoring institutions to organize the investigation of

adverse events.

第十五条 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 15 In addition to the obligations set forth in Article 14 of the Measures, the overseas holder shall also

establish an information transmission mechanism with its designated agent to timely exchange information on the

monitoring and reevaluation of adverse events of medical devices.

第十六条 医疗器械经营企业、使用单位应当履行下列主要义务：

Article 16 Medical device operating enterprises or using units shall fulfill the following main obligations:

（一）建立本单位医疗器械不良事件监测工作制度，医疗机构还应当将医疗器械不良事件监测纳入医疗机构质量安全管理重点工作；

(I) Establish the working system for the monitoring of adverse events of medical devices in the unit; medical

institutions should also incorporate the monitoring of adverse events of medical devices into the key work of the

quality and safety management of medical institutions;

（二）配备与其经营或者使用规模相适应的机构或者人员从事医疗器械不良事件监测相关工作；

(II) Allocate the institutions or personnel appropriate to its operating or using scale to engage in the monitoring of

medical device adverse events;

（三）收集医疗器械不良事件，及时向持有人报告，并按照要求向监测机构报告；

(III) Collect adverse events of medical devices, report them to the holder in a timely manner, and report them to the

monitoring institutions as required;

（四）配合持有人对医疗器械不良事件的调查、评价和医疗器械再评价工作；

(IV) Cooperate with the holder in the investigation, evaluation and reevaluation of medical device adverse events;

（五）配合药品监督管理部门和监测机构组织开展的不良事件调查。

(V) Cooperate with drug regulatory authorities and monitoring institutions to organize the investigation of adverse

events.

第三章 报告与评价

Chapter III Reporting and Evaluation

第一节 基本要求

Section I Basic Requirements

第十七条 报告医疗器械不良事件应当遵循可疑即报的原则，即怀疑某事件为医疗器械不良事件时，均可以作为医疗器械不良事件进行报告。

Article 17 The reporting of adverse events of medical devices should follow the principle of reporting as

suspected, i.e., when an event is suspected to be an adverse event of medical device, it can be reported as an adverse

event of medical device.

报告内容应当真实、完整、准确。

The report shall be authentic, complete and accurate.

第十八条 导致或者可能导致严重伤害或者死亡的可疑医疗器械不良事件应当报告；创新医疗器械在首个注册周期内，应当报告该产品的所有医疗器械不良事件。

Article 18 Suspicious adverse events of medical devices causing or possibly causing serious injury or death

shall be reported; during the initial registration cycle, all adverse events of medical devices of the product should

be reported.

第十九条 持有人、经营企业和二级以上医疗机构应当注册为国家医疗器械不良事件监测信息系统用户，主动维护其用户信息，报告医疗器械不良事件。持有人应当持续跟踪和处理监测信息；产品注册信息发生变化的，应当在系统中立即更新。

Article 19 The holders, operating enterprises and medical institutions at or above Level 2 shall be registered as

the users of the national medical device adverse events monitoring information system, actively maintain the

information of their users and report adverse events of medical devices. The holder shall continuously track and

handle the monitoring information; if the product registration information changes, it shall be updated immediately

in the system.

鼓励其他使用单位注册为国家医疗器械不良事件监测信息系统用户，报告不良事件相关信息。

Other users are encouraged to register as the users of the national medical device adverse event monitoring

information system and report the information of relevant adverse event.

第二十条 持有人应当公布电话、通讯地址、邮箱、传真等，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，并上报体医疗器械不良事件调查报告以及定期风险评价报告等。

Article 20 The holder shall publish contact information such as telephone number, mailing address, email

address, fax, etc., designate contacts, and take the initiative to collect information of adverse events from medical

device operating enterprises, using units and users; for suspected medical device adverse events found or known,

the holder shall report and evaluate the medical device adverse events directly through the national medical device

adverse events monitoring information system, and submit mass medical device adverse event investigation report

and periodic risk evaluation report.

医疗器械经营企业、使用单位发现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。

If a medical device operating enterprise or using unit finds or becomes aware of a suspected medical device adverse

event, it shall promptly notify the holder and report it through the national medical device adverse event monitoring

information system. If the conditions for online reporting are not available, a report shall be submitted to the local

monitoring institutions at or above the county level through a paper report, which shall be submitted online by

monitoring institutions on behalf.

各级监测机构应当公布电话、通讯地址等。

Monitoring institutions at all levels shall publish such contact information as telephone number, mailing address,

etc.

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 21 The holder shall analyze and evaluate the monitoring information of adverse events of medical

devices collected and obtained, and take the initiative to conduct research on the safety of medical the

medical devices subject to conditional approval, the holder shall also carry out relevant work in accordance with

the risk control plan.

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 22 The holder, operating enterprise and using unit shall establish and keep records of the monitoring of

adverse events of medical devices. Records shall be kept for 2 years after the expiry date of the medical device; if

there is no validity period, the preservation period shall not be less than 5 years. The monitoring records of

implantable medical devices shall be kept permanently, and medical institutions shall keep them in accordance with

relevant regulations on cases.

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。

Article 23 Provincial-level monitoring institutions shall comprehensively analyze the reports of adverse events

concerning medical devices registered or filed within their administrative areas, put forward recommendations for

the regulatory measures for the risks detected, and report to the local drug regulatory authorities of the provinces,

autonomous regions or municipalities directly under the central government and the national monitoring

institution within 30 days after the end of each quarter.

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。

The national monitoring institution shall make a comprehensive analysis of the reports on adverse events of medical

devices approved for registration or filing by SDA and the quarterly reports of the drug regulatory departments of

provinces, autonomous regions and municipalities directly under the central government, and when necessary, make

suggestions on the regulatory measures to SDA.

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。

Article 24 Provincial-level monitoring institutions shall summarize and analyze the monitoring of adverse

events concerning medical devices registered or filed within their administrative areas annually, form annual

summary report, and report to the local drug regulatory authorities of the provinces, autonomous regions or

municipalities directly under the central government and the national monitoring institutions before March 15 of

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。

National monitoring institution shall summarize and analyze the annual monitoring situation of adverse events of

medical devices nationwide, form an annual report and report it to SDA before the end of March each year.

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。

The drug regulatory authorities at or above the provincial level shall report the annual report to the health

administrative departments at the same level.

第二节 个例医疗器械不良事件

Section II Individual Medical Device Adverse Event

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。

Article 25 If the holder finds or becomes aware of any suspected adverse event of medical device, he shall

immediately investigate the cause and report the death within 7 days; if serious injury is caused or serious injury or

death may be caused, report 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。

If a medical device operating enterprise or a using unit finds or becomes aware of a suspected medical device

adverse event, it shall promptly notify the holder. Among them, if death is caused, it shall be reported within 7 days;

if serious injury is caused or serious injury or death may be caused, it shall be reported through the national medical

device adverse event monitoring information system within 20 days.

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 26 If any entity or individual other than the holder, the operating enterprise or using unit finds an adverse

event of medical device that causes or may cause serious injury or death, it shall report it to monitoring institutions

or may also report to the holder, the operating enterprise or the medical institution responsible for the treatment; if

necessary, relevant medical records should be provided.

第二十七条 进口医疗器械的持有人和在销售国产医疗器械的持有人，应当主动收集其产品在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，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 27 The overseas holders of imported medical devices and the holders selling domestic medical devices

overseas shall take the initiative to collect adverse events of medical devices of their products occurred overseas. If

serious injury or death is caused or may be caused, the agent designated by the overseas holder and the holder of

domestic medical devices shall report within 30 days from the date of discovery or learning.

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 28 The municipal monitoring organizations with districts shall, within 10 days from the date of receiving

the report on adverse events of medical devices, review the authenticity, integrity and accuracy of the report and

give real-time feedback to the relevant holders.

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 29 The holder shall conduct follow-up investigation, analysis and evaluation as required after reporting

adverse events of medical devices or after receiving relevant adverse events of medical devices through the national

medical device adverse event monitoring information system, and report the evaluation reports to the local

provincial monitoring institutions within 30 days for the event causing death and within 45 days for the events

causing serious injury or possibly causing serious injury or death. If there are new findings or cognitions regarding

the circumstances of the event and the evaluation results, supplementary reports shall be made.

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。

Article 30 The provincial-level monitoring institution where the holder is located shall complete the review of

the evaluation results within 10 days after receiving the evaluation results of the holder. If necessary, it may entrust

or cooperate with the provincial monitoring authorities where the adverse events occurred to conduct on-site

investigation on the adverse events that caused or may cause serious injury or death. Among them, for the medical

devices approved for registration by SDA, the national monitoring institution should also reexamine the results of

evaluation and review made by the provincial monitoring institution, and may organize the investigation of adverse

events causing death if necessary.

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。

The results of the review and reexamination shall be fed back to the holder. If there is any objection to the evaluation

result of the holder, the holder may be asked to conduct reevaluation.

第三节 体医疗器械不良事件

Section III Mass Medical Device Adverse Event

第三十一条 持有人、经营企业、使用单位发现或者获知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。

Article 31 The holder, operating enterprise or using unit shall report the adverse event by telephone or fax to

the drug regulatory authorities of the province, autonomous region or municipality directly under the central

government and the health administrative department where the adverse event occurs within 12 hours after finding

or becoming aware of mass medical device adverse event; if necessary, may report by bypassing the intermediate

leadership and at the same time report the basic information of mass medical device adverse event through the

national medical device adverse event monitoring information system. Each event should also be reported within

24 hours as individual case.

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。

The drug regulatory authorities of the province, autonomous region or municipality directly under the central

government where the adverse event occurred shall promptly inform the drug regulatory authorities of the province,

autonomous region or municipality directly under the central government where the holder is located of relevant

information.

第三十二条 持有人发现或者获知其产品的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。

Article 32 The holder shall immediately suspend the production and sale of medical devices and notify the using

unit to stop using the relevant medical devices after finding or becoming aware of mass medical device adverse

event of its products; at the same time, it shall carry out investigation and self-inspection of production quality

management system, and report to the local drug regulatory authorities and monitoring authorities of provinces,

autonomous regions and municipalities directly under the central government where the adverse event

occurred within 7 days.

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 investigation shall include the quality status of the product, the relevance between the injury and the product,

the compliance of the operation in the using link and the circulation process, etc. Self-inspection shall include

procurement, production management, quality control, tracking of the products of the same type and batch.

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。

The holder shall analyze the cause of the event and release the risk information in a timely manner, report the

conditions of self-inspection and the control measures taken to the drug regulatory authorities of the province,

autonomous region or municipality directly under the central government where the adverse event occurred; if

necessary, relevant medical devices shall be recalled.

第三十三条 医疗器械经营企业、使用单位发现或者获知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 33 If a medical device operating enterprise or using unit finds or becomes aware of any mass medical

device adverse event, it shall notify the holder within 12 hours, carry out self-inspection promptly, and

cooperate with the holder in carrying out an investigation. Self-inspection shall include product storage, circulation

process tracking, and tracking of the product of the same model and batch; the self-inspection of the using unit shall

also include whether the use process conforms to the operating specifications and the requirements of the product

instructions. If necessary, the medical device operating enterprise and the using unit shall suspend the sale and use

of medical devices, and assist the relevant units to take relevant control measures.

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 34 The drug regulatory authorities of the province, autonomous region or municipality directly under

the central government shall carry out on-site investigations in a timely manner after becoming aware of the mass

medical device adverse event occurred within respective administrative area in conjunction with the health

department at the same level. The relevant drug regulatory authorities of provinces, autonomous regions and

municipalities directly under the central government shall cooperate. The investigation, evaluation and handling

results shall be reported to SDA and the health administrative department under the State Council in a timely manner

and a copy shall be made for the drug regulatory authorities of the province, autonomous region or municipality

directly under the central government where the holder is located.

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。

Article 35 SDA shall, in conjunction with the health administrative department under the State Council,

organize the investigation and handling of the mass medical device adverse event having great impact nationwide

and caused serious injury or death and other serious consequences. National monitoring institution shall be

responsible for on-site investigation and the relevant drug regulatory authorities and health administrative

department of provinces, autonomous regions and municipalities directly under the central government shall

cooperate.

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。

The investigation shall include the occurrence of medical device adverse event, the use of medical devices, the

diagnosis and treatment of patients, previous similar adverse events, the production process of products, the storage

and circulation of products, and the tracking of products of the same type and batch.

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 36 National monitoring institution and the relevant drug regulatory authorities and health administrative

department of provinces, autonomous regions and municipalities directly under the food shall, within 5 days after

the end of the investigation, conduct technical evaluation on the risks of the product according to the investigation

and put forward control measures, form investigation report, and report to SDA and the health administrative

department under the state council.

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体不良事件涉及的持有人开展现场检查。

Article 37 The drug regulatory authorities of the province, autonomous region or municipality directly under

the central government where the holder is located may conduct on-site inspection on the holder involved in mass

adverse events. If necessary, SDA may conduct on-site inspections on the foreign holders involved in mass adverse

events.

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。

The on-site inspection shall include the operation of the production quality management system, the quality status

of products, the production process, and the tracking of the products of the same model and batch.

第四节 定期风险评价报告

Section IV 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 38 The holder shall conduct continuous research on the safety of marketed medical devices, summarize

and analyze the adverse event reports, monitoring data and domestic and foreign risk information of the products,

evaluate the risks and benefits of the products, record the risk control measures taken, and prepare post-market

periodic risk evaluation reports.

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。

Article 39 The holder shall complete the post-market periodic risk evaluation report of the products in the

previous year within 60 days after each full year from the date when the products are approved for registration or

put on record for the first time. Among them, those registered with SDA shall be submitted to national monitoring

institution; those registered with the drug regulatory authorities of a province, autonomous region or municipality

directly under the central government shall be submitted to the local provincial monitoring institutions. The periodic

risk evaluation report of Class I medical devices shall be retained by the holder for reference.

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。

For the medical device approved for registration renewal, the periodic risk evaluation report within the current

registration cycle shall be completed before applying for the registration renewal next time and retained by the

holder for reference.

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 40 The monitoring institutions at or above the provincial level shall organize the review on the post-market periodic risk evaluation report on the medical device products received. If necessary, the opinions of the

review shall be reported to the holder.

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。

Article 41 Provincial monitoring institutions shall comprehensively analyze the post-market periodic risk

evaluation reports received and report the statistics and analysis and evaluation results of the post-market periodic

risk evaluation report for the previous year to national monitoring institution and local drug regulatory authorities

of the province, autonomous region and municipality directly under the central government before May 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。

National monitoring institution shall comprehensively analyze the statistics and analysis and evaluation results of

the post-market periodic risk evaluation reports received and the reports submitted by the provincial monitoring

institutions, and report the statistics and analysis and evaluation results of the post-market periodic risk evaluation

report for the previous year to SDA before July 1 of each year.

第四章 重点监测

Chapter IV Intensive Monitoring

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 42 The drug regulatory authorities at or above the provincial level may organize and carry out intensive

monitoring of medical devices and strengthen the post-market risk research on medical devices.

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。

Article 43 SDA shall, in conjunction with the health administrative department under the State Council,

determine the varieties of the medical devices under intensive monitoring, organize and develop the intensive

monitoring work plan and supervise the implementation.

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 varieties of the medical devices under the national intensive monitoring shall be determined according to the

registration of medical devices, the monitoring of adverse events, the supervision and examination, inspection and

other situations, in combination with the risk degree and the use of the product.

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。

National monitoring institutions shall organize and implement the intensive monitoring of medical devices and

complete relevant technical reports. Drug regulatory authorities may take necessary management measures

according to the risks found in the monitoring.

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 44 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under

the central government may, according to the requirements of the supervision and management on medical

devices within their respective administrative areas and with reference to the provisions in Article 43 of the

Measures, carry out provincial intensive monitoring of medical devices for the Class II medical devices registered

and the Class I medical devices filed within respective administrative areas.

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 45 The holder involving in the varieties of medical devices under intensive monitoring shall carry out

its work according to the requirements of the medical device intensive monitoring work plan, actively collect

relevant risk information such as adverse event reports of its products, prepare risk evaluation reports, and submit

them to the organization department for the intensive monitoring as required.

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 46 The drug regulatory authorities at or above the provincial level may designate the units with certain

conditions as monitoring outposts to actively collect intensive monitoring data. Monitoring outposts shall provide

the information on the use of the varieties of medical devices under intensive monitoring, actively collect and report

the information on the monitoring of adverse events, organize or recommend relevant experts to carry out or

cooperate with the monitoring institutions in carrying out scientific research related to risk 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。

Article 47 The holder of innovative medical devices shall strengthen the active monitoring of innovative

medical devices, develop product monitoring plan, actively collect adverse event reports and product complaints,

and conduct investigation, analysis and evaluation.

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。

The holder of innovative medical devices shall, within the first registration cycle, submit a summary report on the

monitoring and evaluation of the adverse events of the product to national monitoring institution every half a year.

The national monitoring institution shall promptly report to SDA any information found to be potentially seriously

defective in medical devices.

第五章 风险控制

Chapter V Risk Control

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：

Article 48 The holder shall, through the monitoring of adverse events of medical devices, take the following

risk control measures according to the circumstances and report to the local drug regulatory authorities of provinces,

autonomous regions and municipalities directly under the central government for the medical devices found with

irrational risks threatening human health and life safety:

（一）停止生产、销售相关产品；

(I) Stop to produce and sell relevant products;

（二）通知医疗器械经营企业、使用单位暂停销售和使用；

(II) Notify the medical device operating enterprise and using unit to suspend the sale and use of the medical device;

（三）实施产品召回；

(III) Implement product recall;

（四）发布风险信息；

(IV) Release risk information;

（五）对生产质量管理体系进行自查，并对相关问题进行整改；

(V) Conduct self-inspection on production quality management system and rectify relevant problems;

（六）修改说明书、标签、操作手册等；

(VI) Modify instructions, labels, operating manual, etc.;

（七）改进生产工艺、设计、产品技术要求等；

(VII)

(VIII)

Improve production process, design and product technical requirements, etc.;

Carry out medical device reevaluation;

（八）开展医疗器械再评价；

（九）按规定进行变更注册或者备案；

(IX) Handle change of registration or filing as required;

（十）其他需要采取的风险控制措施。

(X) Other risk control measures to be taken.

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。

The holder shall promptly disclose to the public the risks and handling situations related to the safety in the use of

medical device.

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 49 If the drug regulatory authorities consider that the control measures adopted by the holder are

insufficient to effectively prevent risks, it may take such measures as issuing warning information, suspending

production, sale and use, ordering recall, requiring the holder to modify the instructions and labels, organizing

reevaluation, and organizing the supervision and inspection on the holder.

第五十条 对发生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。

Article 50 The drug regulatory authorities at or above the provincial level may, according to the risk situation,

take control measures such as suspension of production, sale and use, organize the supervision and inspection on

the holders, and timely release warning and handling information to the public for the medical devices with mass

adverse events reported. After the conclusion of technical evaluation is worked out, the drug regulatory authorities

at or above the provincial level shall, in accordance with the requirements of relevant regulations, take further

regulatory measures and strengthen the monitoring of adverse events of similar medical devices.

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。

The health administrative departments at the same level shall suspend the use of relevant medical devices by medical

institutions within their respective administrative regions and take measures to actively organize treatment of

patients. Relevant holders shall cooperate.

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、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。

Article 51 Monitoring institutions at or above the provincial level should put forward risk management opinions,

timely feedback to the holder and report to appropriate drug regulatory authorities if unreasonable risk of medical

device is found during the evaluation and review on medical device adverse event, quarterly and annual

summarization and analysis on adverse event reports, evaluation on mass adverse events, intensive monitoring, and

periodic risk evaluation report.

Provincial-level monitoring institutions shall also report to the national monitoring institution.

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。

The holder shall formulate and implement appropriate risk control measures according to the risk management

opinions received.

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 52 The drug regulatory authorities and the health administrative departments at all levels may authorize

the medical device testing institution with appropriate qualification to test the products involved in medical device

adverse events if necessary. The medical device testing institution shall promptly carry out the relevant test and

issue the test report.

第五十三条 进口医疗器械在发生医疗器械不良事件，或者国产医疗器械在发生医疗器械不良事件，被采取控制措施的，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 53 If control measures are taken for the occurrence of medical device adverse event of imported medical

device overseas or domestic medical devices overseas, the agent designated by the overseas holder or the holder of

domestic medical devices shall report the overseas medical device adverse events, control measures and the control

measures to be taken domestically to SDA and the national monitoring institution within 24 hours after becoming

aware of it, make a copy to the drug regulatory authorities of the local province, autonomous region or municipality

directly under the central government, and timely report the follow-on handling.

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。

Article 54 If a suspected adverse event of medical devices is caused by the quality of medical devices, the drug

regulatory authorities shall deal with it in accordance with the relevant laws and regulations on medical devices. If

it is caused by applicaiton of medical devices, the health administration department shall dispose of it.

第六章 再评价

Chapter VI Reevaluation

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：

Article 55 In any of the following circumstances, the holder shall take the initiative to carry out the reevaluation

and take appropriate measures according to the reevaluation conclusion:

（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；

(I) According to the development of scientific research, the cognition of the safety and effectiveness of medical

devices has changed;

（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；

(II) The monitoring and evaluation results of medical device adverse events indicate that there may be defects in

medical devices;

（三）国家药品监督管理局规定应当开展再评价的其他情形。

(III) Other circumstances under which reevaluation should be conducted as prescribed by SDA.

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 56 The holder carrying out the reevaluation of medical devices shall conduct reevaluation on the such

technical data and contents as the summary data, research data, clinical evaluation data, risk analysis data of product,

technical requirements of product, instructions, labels, etc. in the original registration materials for medical device

according to the information about the safety and effectiveness of the post-market product learned and mastered,

clinical data and use experience, etc.

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 57 The reevaluation report shall include product risk and benefit assessment, socio-economic benefit

assessment, technological progress assessment, proposed measures and suggestions, etc.

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。

Article 58 If the holder takes the initiative to carry out medical device reevaluation, the reevaluation work plan

shall be formulated. If control measures should be taken as determined through reevaluation, the reevaluation report

shall be submitted within 15 days after forming the conclusion of reevaluation. Among them, for the medical device

approved for registration or filing by SDA, the holder should submit the reevaluation report to the national

monitoring institution; the holder of other medical devices shall submit the reevaluation report to the local provincial

monitoring institution.

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。

If the holder fails to fulfill the obligation for reevaluation of medical devices as prescribed, the drug regulatory

authority at or above the provincial level shall order the holder to carry out reevaluation. If necessary, the drug

regulatory authorities at or above the provincial level may directly organize and carry out reevaluation.

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。

Article 59 If the drug regulatory authority at or above the provincial level orders the holder to carry out the

reevaluation, the holder should submit the reevaluation plan and reevaluation report to the relevant drug regulatory

authority and the monitoring institution within 30 days before and after the reevaluation.

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。

If the reevaluation period exceeds one year, the holder shall report the annual progress every year.

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。

Article 60 Monitoring institution shall review the reevaluation report of the holder received and report the

opinions of review to the relevant drug regulatory authorities.

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。

If drug regulatory authorities have any objection to the reevaluation conclusion of the holder, the holder shall re-verify the reevaluation results or carry out the reevaluation again according to the requirements of the drug

regulatory authorities.

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 61 If medical device reevaluation is organized and conducted by drug regulatory authorities, the

reevaluation plan shall be formulated by the designated monitoring institution and shall not be organized and

implemented until approved by the drug regulatory authorities organizing the reevaluation. After the reevaluation

report is formed, it shall be reported to appropriate drug regulatory authorities.

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。

Article 62 If reevaluation results show that the defect endangering the personal safety exists with the medical

device registered or filed and the risks cannot be eliminated or controlled through technical improvement, modifying

instructions and labels, etc., the holder shall apply for cancellation of medical device registration certificate or cancel

the filing of the product with initiative; if the holder applies for the cancellation of medical device registration

certificate or cancellation of filing, the medical device registration certificate or the filing may be cancelled by the

original issuing department. The drug regulatory authorities shall promptly release the information concerning the

cancellation of medical device registration certificate or filing to the public.

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。

SDA may make decision on the elimination of the variety of medical device according to the conclusion of the

reevaluation. For the product eliminated, the medical device registration certificate or product filing shall be

cancelled by the original issuing department.

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。

The medical devices with the medical device registration certificate or filing cancelled shall not be produced,

imported, operated or used.

第七章 监督管理

Chapter VII Supervision and Management

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 63 The drug regulatory authorities shall conduct supervision and inspection on the monitoring and

reevaluation of adverse events of medical devices of the holder and operating enterprises based on their

responsibilities, and together with health administrative departments at the same level, carry out supervision and

inspection on the monitoring of medical device adverse events of medical device using unit.

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 64 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under

the central government shall formulate plans for the supervision and inspection on the monitoring of adverse events

of medical devices in their respective administrative areas, determine the key points for inspection, and supervise

their implementation.

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 65 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under

the central government shall strengthen the training and assessment for the personnel engaged in the monitoring and

reevaluation of adverse events of medical devices within their respective administrative areas.

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 66 The drug regulatory authority shall conduct supervision and inspection on the construction and

implementation of the holder’s adverse event monitoring system in accordance with the requirements of regulations,

rules and norms. If necessary, extended inspection may be carried out on the enterprise authorized by the holder to

conduct relevant work.

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：

Article 67 In any of the following circumstances, the drug regulatory authorities shall carry out intensive

inspection on the holder:

（一）未主动收集并按照时限要求报告医疗器械不良事件的；

(I) Failing to collect and report adverse events of medical device according to the specified time;

（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；

(II) The number of the adverse events that caused or may cause serious injury or death reported by the holder is

greatly different from the number reported by the medical institution, indicating that the subject responsibility has

not been fulfilled;

（三）瞒报、漏报、虚假报告的；

(III) Concealing, failing to report or making false reports;

（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；

(IV) Failing to cooperate in the investigation of medical device adverse events carried out by drug regulatory

authorities and to and take control measures;

（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。

(V) Failing to collect product safety information through adverse event monitoring as required, or failure to carry

out post-market research and reevaluation as required and inability to guarantee the safety and effectiveness of the

product.

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。

Article 68 If the holder fails to establish the monitoring system for adverse events as required, to carry out the

monitoring and reevaluation of adverse events, to take effective risk control measures in a timely manner according

to the provisions in Article 48 of the Measures, or to cooperate with drug regulatory authorities to conduct

investigation and take control measures for adverse events of medical devices, drug regulatory authority may ask

the holder to stop production for rectification and, if necessary, to take control measures to stop product sales.

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。

If the production and sales need to be resumed, the holder shall submit an application to the drug regulatory

authorities that made the decision on the treatment. After the on-site inspection is accepted by the drug regulatory

authorities, a decision on the resumption of production and sales shall be made.

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。

Before applying for the resumption of production and sales, the holder may employ an independent third-party

professional institution with corresponding qualification to provide inspection and verification.

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：

Article 69 The drug regulatory authorities at or above the provincial level shall uniformly release the following

monitoring information on adverse events of medical devices:

（一）体医疗器械不良事件相关信息；

(I) Information of mass medical device adverse event;

（二）医疗器械不良事件监测警示信息；

(II) Warning information about the monitoring of adverse events of medical devices;

（三）需要定期发布的医疗器械不良事件监测信息；

(III) Information about the monitoring of medical device adverse event to be released periodically;

（四）认为需要统一发布的其他医疗器械不良事件监测信息。

(IV) Other information about the monitoring of medical device adverse event deemed as necessary to release

uniformly.

第八章 法律责任

Chapter VIII Legal Responsibility

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；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：

Article 70 In any of the following circumstances, the holder shall be ordered to make corrections and given

a warning by the drug regulatory authorities at or above the county level in accordance with Article 68 of the

Regulations for the Supervision and Administration of Medical Devices; those who refuse to make corrections shall

be fined not less than RMB 5,000 but not more than RMB 20,000; if the circumstances are serious, it shall be ordered

to suspend production or business operations until the relevant supporting documents are revoked by the issuing

department:

（一）未主动收集并按照时限要求报告医疗器械不良事件的；

(I) Failing to collect and report adverse events of medical device according to the specified time;

（二）瞒报、漏报、虚假报告的；

(II) Concealing, failing to report or making false reports;

（三）未按照时限要求报告评价结果或者提交体医疗器械不良事件调查报告的；

(III) Failing to report the evaluation results or submit the investigation report on the mass medical device adverse

events according to the specified time;

（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。

(IV) Failing to cooperate with drug regulatory authorities and monitoring institutions to carry out the investigation

of medical device adverse events and take control measures.

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；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：

Article 71 In any of the following circumstances, the medical device operating enterprise or using unit shall be

ordered depending on their respective responsibilities to make corrections and given a warning by the drug

regulatory authorities and health administrative department at or above the county level in accordance with Article

68 of the Regulations for the Supervision and Administration of Medical Devices; those who refuse to make

corrections shall be fined not less than RMB 5,000 but not more than RMB 20,000; if the circumstances are serious,

it shall be ordered to suspend production or business operations until the relevant supporting documents are revoked

by the issuing department:

（一）未主动收集并按照时限要求报告医疗器械不良事件的；

(I) Failing to collect and report adverse events of medical device according to the specified time;

（二）瞒报、漏报、虚假报告的；

(II) Concealing, failing to report or making false reports;

（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。

(III) Failing to cooperate with drug regulatory authorities and monitoring institutions to carry out the investigation

of medical device adverse events and take control measures.

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。

Article 72 If the holder fails to carry out the reevaluation or conceals the reevaluation results as required, or

fails to submit the cancellation application, it shall be ordered to make correction and given a warning by the drug

regulatory authorities at or above the provincial level and may concurrently be fined not less than RMB 10,000 but

not more than RMB 30,000.

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：

Article 73 In any of the following circumstances, the holder shall be ordered to make corrections and given

a warning by the drug regulatory authorities at or above the county level; those who refuse to make corrections shall

be fined not less than RMB 5,000 but not more than RMB 20,000:

（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；

(I) Failing to establish a work system for monitoring and reevaluating adverse events of medical devices in

accordance with relevant regulations;

（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；

(II) Failing to allocate the institutions and personnel appropriate to its products to engage in the monitoring of

medical device adverse events;

（三）未保存不良事件监测记录或者保存年限不足的；

(III) Failing to keep records for monitoring adverse events or failing to keep them for a sufficient period of time;

（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；

(IV) Failing to register as a user of medical device adverse event monitoring information system as required;

（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；

(V) Failing to actively maintain user information, or failing to continuously track and process monitoring

information;

（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；

(VI) Failing to take corresponding control measures according to the situation of adverse events and make public;

（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；

(VII)

(VIII)

Failing to prepare, submit or retain post-market periodic risk evaluation reports as required;

Failing to report adverse events of overseas medical devices and overseas control measures as required;

（八）未按照要求报告医疗器械不良事件和控制措施的；

（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；

(IX) Failing to submit a summary report on the analysis and evaluation of innovative medical devices as required;

（十）未公布、主动收集不良事件信息的；

(X) Failing to publish contact information or actively collect information about adverse events;

（十一）未按照要求开展医疗器械重点监测的；

(XI) Failing to carry out intensive monitoring of medical devices as required;

（十二）其他违反本办法规定的。

(XII) Other violations of the provisions of the Measures.

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：

Article 74 In any of the following circumstances, the medical device operating enterprise or using unit shall be

ordered depending on respective responsibilities to make corrections and given a warning by the drug regulatory

authorities and health administrative department at or above the county level; those who refuse to make corrections

shall be fined not less than RMB 5,000 but not more than RMB 20,000:

（一）未按照要求建立医疗器械不良事件监测工作制度的；

(I) Failing to establish a work system for monitoring adverse events of medical devices in accordance with relevant

regulations;

（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；

(II) Failing to allocate the institutions or personnel appropriate to its operating or using scale to engage in the

monitoring of medical device adverse events;

（三）未保存不良事件监测记录或者保存年限不足的；

(III) Failing to keep records for monitoring adverse events or failing to keep them for a sufficient period of time;

（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；

(IV) Failing to register as a user of medical device adverse event monitoring information system as required;

（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；

(V) Failing to promptly report to the holder any adverse event of medical devices collected or known;

（六）未配合持有人对医疗器械不良事件调查和评价的；

(VI) Failing to cooperate with the holder in the investigation and evaluation of medical device adverse events;

（七）其他违反本办法规定的。

(VII) Other violations of the provisions of the Measures.

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 drug regulatory authorities find that the using unit has committed any of the act prescribed in the preceding

paragraph, it shall transfer the matter to the health administrative department at the same level for handling.

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。

If the health and family planning administrative department makes a decision on administrative punishment for the

using unit, it shall promptly notify the food and drug regulatory authorities at the same level.

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 75 If a holder, an operating enterprise or a using unit reports, investigates, evaluates or disposes medical

device adverse events according to the requirements of the Measures, and voluntarily eliminates or mitigates the

consequences of such act, the punishment on the relevant illegal act shall be reduced or mitigated in accordance with

the provisions of the Law of the People’s Republic of China on Administrative Penalties. If the illegal act is minor

and not promptly corrected, and no harmful consequences have been caused, no penalty shall be imposed, but other

legal liability to be undertaken according to law shall be not exempted.

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 76 If the drug regulatory authorities at all levels, the health administrative departments, the monitoring

institutions and their staff fail to perform their duties as prescribed, they shall be dealt with in accordance with the

provisions in Article 72 and Article 74 of the Regulations for the Supervision and Administration of Medical Devices.

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。

Article 77 If the holder, the operating enterprise or the using unit violates relevant regulations and causes

damage to the users of medical devices, they shall be liable for compensation according to law.

第九章 附 则

Chapter IX Supplementary Provisions

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。

Article 78 The contents of medical device adverse event reports, risk analysis and evaluation reports and

statistical data are the basis for strengthening the supervision and management of medical devices and guiding the

rational use of medical devices and shall not be used as the basis for medical disputes, medical lawsuits and handling

medical device quality accidents.

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。

For medical accidents or quality problems of medical devices, they shall be dealt with separately in accordance with

the requirements of relevant regulations.

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 79 The Measures shall be interpreted by SDA jointly with health administrative department under the

State Council.

第八十条 本办法自2019年1月1日起施行。

Article 80 The Measures shall come into force as of January 1, 2019.