对我国医疗器械不良事件监测系统的思考和建议

医疗器械不良事件的上报数量逐年增加，但上报系统还存在不足之处，导致对不良事件的评价和判定产生困惑。该文根据我国上报的医疗器械不良事件的特点，对上报系统的评价流程提出修订建议，以期实现对不同类型的不良事件以监管目标为导向及时进行有效管理。

Contemplation and Suggestion on the Medical Device Adverse Event Reporting Program

The number of medical device adverse events reported to national monitoring center increased greatly year by year, but the reporting system stil existed some deficiencies which resulting in confusion when fil ing the forms, especial y those selections about relationship evaluation. This paper proposed amendments about event-evaluation process according to the characteristics of medical device adverse events reported in China, in order to perform timely and effectively regulation on different types of adverse events for different purposes.