Chapter 1 General Provisions Article 1 In order to strengthen the monitoring and re-evaluation of adverse events of medical devices, promptly and effectively control post-market risks of medical devices, and protect human health and life safety, according to the "Regulations on the Supervision and Administration of Medical Devices" , formulate these measures. Article 2 These Measures shall apply to the monitoring, re-evaluation and supervision and management 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 holders) shall have the quality management capabilities and corresponding responsibility capabilities to ensure the safety and effectiveness of medical devices, establish a medical device adverse event monitoring system, and report to the medical device adverse event monitoring technical agency (hereinafter referred to as the monitoring agency) directly reports medical device adverse events. Business enterprises and medical device users authorized by the holder to sell medical devices shall report medical device adverse events to the holder and monitoring agencies.

The holder shall evaluate the adverse events discovered, improve product quality based on the evaluation results, and report the evaluation results and quality improvement measures to the monitoring agency; if approval by the original registration authority is required, it shall be submitted in accordance with regulations Apply.

The agent designated by the overseas holder shall be responsible for monitoring adverse events of imported medical devices sold within the country and cooperate with the overseas holder in fulfilling the re-evaluation obligations. Article 4 The meanings of the following terms in these Measures:

(1) Medical device marketing authorization holder refers to the holder of the medical device registration certificate and medical device filing certificate, that is, the medical device registrant and Filer.

(2) Medical device adverse events refer to various harmful events that occur under normal use of medical devices that have been put on the market and cause or may cause human injury.

(3) Serious injury refers to one of the following conditions:

1. Endangering life;

2. Causing permanent damage to body functions Or permanent damage to the body structure;

3. Medical measures must be taken to avoid the above permanent harm or damage.

(4) Group medical device adverse events refer to the occurrence of the same medical device at a relatively concentrated time and area during use, causing damage or threat to the health or life safety of a certain number of people. event.

(5) Medical device adverse event monitoring refers to the process of collecting, reporting, investigating, analyzing, evaluating and controlling adverse events of medical devices.

(6) Key monitoring of medical devices refers to proactive phased monitoring activities carried out to study the risk situation, characteristics, severity, incidence, etc. of a certain variety or product after it is launched.

(7) Medical device re-evaluation refers to the process of re-evaluating the safety and effectiveness of registered, filed, and marketed medical devices and taking corresponding measures. Article 5: The State Food and Drug Administration shall establish a national medical device adverse event monitoring information system and strengthen the construction of medical device adverse event monitoring information networks and databases.

The monitoring agency designated by the State Food and Drug Administration (hereinafter referred to as the national monitoring agency) is responsible for the unified management of collected adverse event information on medical devices and reports it to relevant monitoring agencies, holders, operating enterprises or The user unit provides feedback on information related to adverse event monitoring of medical devices.

Monitoring information related to product use risks should be reported to the health administrative department. 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 systems, equip corresponding monitoring institutions and personnel, and carry out medical device adverse event monitoring. Article 7 Any unit or individual who discovers an adverse event with a medical device has the right to report it to the department responsible for drug supervision and administration (hereinafter referred to as the drug supervision and administration department) or the monitoring agency. Chapter 2 Responsibilities and Obligations Article 8 The State Food and Drug Administration is responsible for the supervision and management of the monitoring and re-evaluation of medical device adverse events across the country, and, in conjunction with the health administration department of the State Council, organizes nationwide activities that have a large impact and cause serious injury or death and other Investigate and handle group medical device adverse events with serious consequences, and take emergency control measures in accordance with the law. Article 9 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the supervision and management of monitoring and re-evaluation of medical device adverse events within their respective administrative regions, and shall organize, in conjunction with the health administrative departments and relevant departments at the same level, the development of mass medical device incidents that occur within their respective administrative regions. Investigate and handle adverse events and take emergency control measures in accordance with the law.

The districted city-level and county-level drug regulatory authorities are responsible for the monitoring of medical device adverse events within their respective administrative regions. Article 10: Higher-level drug regulatory departments guide and supervise lower-level drug regulatory departments to carry out supervision and management of adverse event monitoring and re-evaluation of medical devices. Article 11 The health administrative department of the State Council and local health administrative departments at all levels are responsible for the supervision and management of medical device adverse event monitoring in medical device users, and urge medical device users to carry out work related to medical device adverse event monitoring and organize inspections. Strengthen the assessment of monitoring of medical device adverse events, and adopt relevant control measures for medical device adverse events within the scope of responsibilities and in accordance with the law.

The higher-level health administrative departments guide and supervise the lower-level health administrative departments to carry out supervision and management work related to the monitoring of adverse events of medical devices.