Provisions for Medical Device Adverse Event Monitoring and Re-evaluation

(SAMR Decree No.1)

Issued on August 31, 2018

The Provisions for Medical Device Adverse Event Monitoring and Re-evaluation, approved by the State Administration for Market Regulation and the National Health Commission, is hereby promulgatedand shall be put into force as of January 1, 2019.

Zhang Mao, Minister of State Administration for Market Regulation

Ma Xiaowei, Minister of National Health Commission

August 13, 2018

Provisions for Medical Device Adverse Event Monitoring and Re-evaluation

Chapter I General Provisions

Article 1 In order to strengthen monitoring and re-evaluation of medical device adverse events, promptly and effectively control post-market risks of medical devices and ensure human health and life safety, the Provisions is hereby formulated in accordance with Regulations for the Supervision and Administration of Medical Devices.

Article 2 The Provisions applies to the monitoring, re-evaluation, supervision and administration of medical device adverse events within the territory of the People's Republic of China.

Article 3 Medical device marketing authorization holders (hereinafter referred to as MAHs) shall possess the capacities of quality management and corresponding responsibilities to ensure that the medical devices are safe and effective, establish medical device adverse event monitoring system and directly report medical device adverse events to medical device adverse event monitoring agencies (hereinafter referred to as monitoring agencies). Distributing enterprises and user facility of medical device authorized by MAHs shall report medical device adverse events to MAHs and monitoring agencies.

MAHs shall evaluate the identified adverse events, improve the product quality based on evaluation results and report the evaluation results and measures for quality assurance to monitoring agencies; where review and approval by the original registration authority is required, application shall be submitted in accordance with the regulations.

Agents designated by overseas MAHs shall undertake adverse event monitoring of the imported medical devices sold within the territory of China and cooperate with overseas MAHs to fulfill the obligation of re-evaluation.

Article 4 The terms in the Provisions are defined as follows:

(I)  MAHs of medical device refer to the holders of medical device registration certificate and filing certificate, namely, medical device registrants and filing persons.

(II)  Medical device adverse event refers any harmful event occurred while using marketed medical devices under their normal usage that causes, or is likely to cause, harm to human body.

(III)  Serious damage is defined as the damage that one of the following situations is met:

1.  Life threatening;

2.  Causing permanent harms to body function or injuries to body structure;

3.  Medical measures are required to avoid the above-mentioned permanent harms and injuries.

(IV)  Group adverse event of medical device refers to the events occurred by the same medical device during its use that causes harm or threat for the health or life safety of a certain amount of population within a relatively concentrated time and area.

(V)   Medical device adverse event monitoring refers to the process of collection, reporting, investigation, analysis, evaluation and control of medical device adverse event.

(VI)  Intensive surveillance for medical device refers to the periodic monitoring activities which are performed actively for studying the post-market risks, characteristics, severity, and incidence of some variety or product.

(VII)  Medical device re-evaluation refers to the process of re-evaluating the safety and effectiveness of medical devices registered/filed and sold on the market and taking corresponding measures.

Article 5 National Medical Products Administration (hereinafter referred to as the NMPA) shall establish the National Medical Device Adverse Event Monitoring Information System and strengthen the construction of medical device adverse event monitoring information network and database.

Monitoring agencies designated by the NMPA (hereinafter referred to as national monitoring agencies) shall be responsible for unified management of all the information of medical device adverse events collected and provide feedback of relevant monitoring information of medical device adverse events to relevant monitoring agencies, MAHs, distributing enterprises or user facilities.

Monitoring information related to product use risks shall be reported to Health Administrative Departments.

Article 6 Drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall establish and improve medical device adverse event monitoring system, be equipped with corresponding monitoring agencies and personnel and carry out medical device adverse event monitoring.

Article 7 Where units and individuals discover any medical device adverse event, they have the right to report to authorities of drug supervision and administration (hereinafter referred to as drug regulatory departments) or monitoring agencies.

Chapter II Responsibilities and Obligations

Article 8 The NMPA shall be responsible for the supervision and administration of medical device adverse event monitoring and re-evaluation nationwide, organize the investigation and handling of group adverse events of medical device that has great influence nationwide and causes severe injuries or death and other serious consequences jointly with the Health Administrative Departments of the State Council, and take emergency control measures according to law.

Article 9 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and administration of medical device adverse event monitoring and re-evaluation within their respective administrative regions, organize the investigation and handling of group adverse events of medical device that occurs within their respective administrative regions jointly with the health administrative departments at the same level and relevant authorities, and take emergency control measures according to law.

The drug regulatory departments at the level of the municipality consisting of districts or county level shall be responsible for medical device-related adverse event monitoring within their respective administrative regions.

Article 10 Drug regulatory departments shall guide and supervise subordinate drug regulatory departments in conducting supervision and administration on medical device adverse event monitoring and re-evaluation.

Article 11 Health administrative departments of the State Council and health administrative departments at all levels shall be responsible for supervision and administration of user facility of medical device related to medical device adverse event monitoring, urge user facility of medical device to carry out relevant medical device adverse event monitoring work and organize inspection, strengthen  assessment of medical device adverse event monitoring, and take relevant control measures for medical device adverse events within their responsibility according to law.

Superior health administrative departments shall guide and supervise subordinate health administrative departments to carry out the supervision and administration related to medical device adverse event monitoring.

Article 12 National monitoring agencies shall be responsible for receiving medical device adverse events information reported by MAHs, distributing enterprises and user facility, assume relevant technical works related to medical device adverse event monitoring and re-evaluation nationwide; be responsible for the construction, maintenance and information management of national network and database of monitoring information of medical device adverse event, organize to develop technical specifications and guidelines, organize the investigation, evaluation and feedback of relevant adverse events information of the medical devices approved by the NMPA to be registered, summarize, analyze and guide relevant adverse events information of the medical devices approved by local drug regulatory departments above municipal level to be registered or filed, and investigate and evaluate group adverse events of medical device that have great influence nationwide and cause severe injuries or death and other serious consequences.

Article 13 The monitoring agencies designated by the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government (hereinafter referred to as provincial monitoring agencies) shall organize the technical works related to medical device adverse event monitoring and re-evaluation within their respective administrative regions; assume the investigation, evaluation and feedback of adverse events of the medical devices registered or filed within their respective administrative regions, and investigate and evaluate group adverse events of medical device that occurs within their respective administrative regions.

The monitoring agencies at the level of the municipality consisting of districts or county level shall assist in carrying out technical works related to medical device adverse event monitoring within their respective administrative regions.

Article 14 MAHs shall carry out continuous research on the medical devices already marketed, evaluate the risks, assume the responsibilities of medical device adverse event monitoring, take effective control measures based on the analysis and evaluation results, and fulfill the following main obligations:

(I)  Establishing a medical device quality management system that incorporates medical device adverse event monitoring and re-evaluation working mechanism;

(II) Equipped with the organization and personnel corresponding to the products to carry out relevant works of medical device adverse event monitoring;

(III) Proactively collecting and truthfully and promptlyreporting medical device adverse events to monitoring agencies according to the time limit stipulated in the Provisions;

(IV) Promptly investigating, analyzing and evaluating medical device adverse events occurred, and promptlytaking measures to control risks and release risk information;

(V)  Conducting continuous study on the safety of medical devices once they are on the market, and write periodic risk evaluation reports as required;

(VI) Actively carrying out medical device re-evaluation;

(VII) Cooperating with drug regulatory departments and monitoring agencies in investigation of medical device adverse events.

Article 15 In addition to fulfilling the obligations stipulated in Article 14 of the Provisions, overseas MAHs shall also establish information transfer mechanism with their designated agents to promptly exchange information related to medical device adverse event monitoring and re-evaluation.

Article 16 Medical device distributing enterprises and user facilities shall fulfill following major obligations:

(I) Establishing medical device adverse event monitoring working mechanism. Medical institutions shall also include medical device adverse event monitoring in medical institution quality management work priorities;

(II) Be equipped with the organization or personnel adapted to the scale of the business or use to carry out relevant works of medical device adverse event monitoring;

(III) Collecting medical device adverse events, promptly reporting to MAHs, and reporting to the monitoring agencies as required;

(IV) Cooperating with MAHs in the investigation and evaluation of medical device adverse events and medical device re-evaluation;

(V) Cooperating with drug regulatory departments and monitoring agencies in the investigation of medical device adverse events.

Chapter III Report and Evaluation

Section I Basic Requirements

Article 17 Medical device adverse events shall be reported based on the principle of "Report When in Doubt", that is, when an event is suspected to be a medical device adverse event, it shall be reported as a medical device adverse event.

The reporting content shall be authentic, complete and accurate.

Article 18 Any suspected medical device adverse events that have caused or possibly caused severe injuries or death shall be reported; for an innovative medical device, all the medical device adverse events shall be reported within initial registration period.

Article 19 MAHs, distributing enterprises and secondary medical institutions or above shall register as the users of the National Medical Device Adverse Events Monitoring Information System, voluntarily maintain the user information and report medical device adverse events. MAHs shall continuously track and handle monitoring information; in case of any change in product registration information, MAHs shall update the information in the system immediately.

Other user facilities are encouraged to register as the users of the National Medical Device Adverse Events Monitoring Information System and report the information related to adverse events.

Article 20 MAHs shall release the contact information such as telephone, correspondence address, email and fax, designate the contact person, and voluntarily collect the adverse event information from medical device distributing enterprises, user facility and users; In case of identifying or knowing any suspected medical device adverse event, MAHs shall report and evaluate the medical device adverse event directly through the National Medical Device Adverse Events Monitoring Information System and submit investigation report of group adverse events of medical device as well as periodic risk evaluation report.

In case of identifying orknowing any suspected medical device adverse event, medical device distributing enterprises and user facility shall notify MAHs and report it through the National Medical Device Adverse Events Monitoring Information System. In case of having no conditions for online report temporarily, MAHs shall report to local monitoring agency above county level in paper form. The monitoring agency shall make online reporting on their behalf.

Monitoring agencies at all levels shall make their contact information open such as telephone and correspondence address.

Article 21 MAHs shall analyze and evaluate the medical device adverse event monitoring information collected and informed and actively carry out the study on medical device safety. For the medical device with conditional approval, MAHs shall carry out relevant works according to risk control plan.

Article 22 MAHs, medical device distributing enterprises as well as user facility shall establish and keep medical device adverse event monitoring records. The records shall be kept until 2 years upon shelf life expiration of medical devices; for those without shelf life label, the record-keeping 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 the relevant provisions for medical records.

Article 23 Provincial monitoring agencies shall carry out comprehensive analysis on adverse event reports of the medical devices registered or filed within local administrative regions, propose recommendations on supervisory measures for identified risks, and report to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government and national monitoring agencies within 30 days at each quarter end.

National monitoring agencies shall carry out comprehensive analysis on adverse event reports of the medical devices approved by the NMPA to be registered or filed and quarterly reports submitted by all the provinces, autonomous regions and municipalities directly under the central government, and if necessary, propose recommendations on supervisory measures to the NMPA.

Article 24 Provincial monitoring agencies shall yearly carry out Meta-analysis on the medical devices adverse event monitoring information registered or filed within local administrative regions, complete annual summary report, and submit it to local drug regulatory departments of the provinces, autonomous regions and municipalities directly under the central government and national monitoring agencies prior to March 15 each year.

National monitoring agencies shall carry out Meta-analysis on the annual monitoring information of medical device adverse events nationwide, complete annual report and submit it to the NMPA by the end of March each year.

The drug regulatory departments at provincial level or above shall notify the annual reports to the health administrative departments at the same level.