Analysis and Prospect of Medical Device Adverse Event Monitoring Regulations
Medical device adverse events usually refer to various harmful events that occur under normal use of marketed medical devices and cause or may cause human injury.The reporting of adverse events of medical devices shall follow the principle of suspicious reporting,that is,when an event is suspected to be an adverse event of a medical device,it can be reported as an adverse event of a medical device.Common medical device adverse events include injury events and failure events.In recent years,China has continuously strengthened the quality of supervision of medical devices througtout its whole life cycle,continued to accelerate the pace of scientificization,rule of law,internationalization and modernization,and actively promoted the monitoring system of adverse events of medical devices,steadily improved the risk monitoring and vigilance ability of medical devices.As a highly developed economic union in the world,the EU also leads the world in the medical device industry.The rapid development of the medical field is inseparable from strong and scientific supervision.This paper aims to sort out the regulations of China's medical device adverse event monitoring system in recent years,carry our the comparative analysis with the relevant EU laws and regulations,and then put forward thoughts and prospects for the future development of medical device adverse event monitoring.
medical device adverse event monitoringregulatory analysisprospection
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