The holder shall evaluate the adverse events found, improve the quality of the product according to the evaluation results, and report to the monitoring body to evaluate the results and improve the quality of the measures; the need for approval of the original registration authority shall be submitted in accordance with the provisions of the application.
The designated agent of the foreign holder shall undertake the monitoring of adverse events of imported medical devices sold within the territory, and cooperate with the foreign holder to fulfill the obligation of re-evaluation. Article IV of these measures the meaning of the following terms:
(a) medical device marketing authorization holder, refers to the certificate of registration of medical devices and medical devices for the record voucher holder, that is, the medical device registrant and filer.
(b) medical device adverse events, refers to the listed medical devices, in the normal use of the situation occurs, resulting in or may lead to human injury of all kinds of harmful events.
(C) serious injury, refers to one of the following situations:
1. life-threatening;
2. resulting in permanent injury to the function of the body or permanent damage to the structure of the body;
3. medical measures must be taken to avoid the above permanent injury or damage.
(D) group medical device adverse events, refers to the same medical device in the process of use, in a relatively concentrated time, region, to a certain number of people's physical health or life safety damage or threat to the event.
(E) medical device adverse event monitoring, refers to the collection, reporting, investigation, analysis, evaluation and control of the process of medical device adverse events.
(F) medical device key monitoring, refers to the study of a variety or product after the market risk situation, characteristics, severity, incidence, etc., take the initiative to carry out the stage of monitoring activities.
(VII) medical device re-evaluation, refers to the registered or filed, marketed and sold medical devices, the safety and efficacy of re-evaluation, and take appropriate measures for the process. Article 5 The State Drug Administration to establish a national medical device adverse event monitoring information system, to strengthen the medical device adverse event monitoring information network and database construction.
The State Drug Administration designated monitoring organization (hereinafter referred to as the national monitoring agency) is responsible for the collection of medical device adverse event information for unified management, and to the relevant monitoring organization, the holder, the operating company or the use of unit feedback medical device adverse event monitoring information.
Monitoring information related to the risk of product use shall be notified to the administrative department of health. Article 6 Provinces, autonomous regions, municipalities directly under the Central Drug Administration shall establish medical device adverse event monitoring system, improve the relevant system, with appropriate monitoring organizations and personnel, to carry out medical device adverse event monitoring work. Article 7 Any unit or individual found adverse events of medical devices, the right to the drug supervision and management department (hereinafter referred to as the drug supervision and management department) or monitoring organization to report. Chapter II Responsibilities and Obligations Article 8 The State Drug Administration is responsible for the supervision and management of national monitoring and re-evaluation of adverse events of medical devices, in conjunction with the State Council administrative department of health to organize and carry out the investigation and treatment of the group of adverse events of medical devices that have a large impact on a national scale and cause serious injury or death as well as other serious consequences, and to take emergency control measures in accordance with the law. Article 9 Provinces, autonomous regions, municipalities directly under the Central Drug Administration is responsible for the monitoring and re-evaluation of medical device adverse events in the administrative region of the supervision and management, in conjunction with the health administrative departments at the same level and relevant departments to organize and carry out the investigation and handling of group medical device adverse events occurring in the administrative region, and to take urgent control measures according to law.
The municipal and county drug supervision and management departments are responsible for the monitoring of adverse events of medical devices in the administrative area. Article 10 The higher drug supervision and management department to guide and supervise the lower drug supervision and management department to carry out the supervision and management of medical device adverse event monitoring and re-evaluation. Article 11 The health administration department of the state council and local health administration departments at all levels are responsible for the supervision and management of medical device use units related to the monitoring of adverse events of medical devices, supervise the use of medical devices to carry out the monitoring of adverse events of medical devices and organize inspections, strengthen the assessment of the monitoring of adverse events of medical devices, and take relevant control measures for the monitoring of adverse events of medical devices according to law in the scope of responsibilities. The control measures.
Superior health administrative departments to guide and supervise the lower level of health administrative departments to carry out supervision and management work related to the monitoring of adverse events of medical devices.