At present, medical device marketing authorization holders, who are the main responsibility for core safety, are not able to perform their duties in accordance with the regulations, and they lack the necessary attention to the monitoring of adverse events. There is still a misunderstanding of adverse event monitoring and a misjudgment of the scope of adverse events in the industry. With the continuous improvement of the whole life cycle responsibility system and the related regulatory policy

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... entation of the listed licensee, the licensee must pay attention to the adverse event monitoring compliance, or else there will be regulatory risks that cannot be addressed. On July 28, 2020, the State Drug Administration of the People's Republic of China issued the Opinions on Further Strengthening the Monitoring and Evaluation System and Capacity Building for Adverse Drug Reactions (SFDA [2020] No. 20), which provides systematic advice on further strengthening the monitoring and evaluation system and capacity building for adverse drug reactions, emphasizing guidance and urging holders to implement their main responsibilities for drug safety. In accordance with the requirements of the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices (hereinafter referred to as "the Measures"), the holder of a medical device listing permit (hereinafter referred to as the holder) shall have the ability to ensure the safety and effectiveness of medical devices in terms of quality management and corresponding responsibility, establish a medical device adverse event monitoring system, and provide the medical device adverse event monitoring technical institutions (hereinafter referred to as the monitoring body) to report medical device adverse events directly. The business enterprise and medical device user unit authorized by the holder to sell shall report the medical device adverse event to the holder and the monitoring body.