从持有人视角对医疗器械不良事件监测和再评价工作现状的调查与思考  

Investigation and Reflection on Medical Equipment Adverse Event Monitoring and Re-Evaluation from the Perspective of Holders

作　　者：闫舒 刘莹 Yan Shu;Liu Ying(Center for ADR Monitoring of Zhenjiang,Zhenjiang Jiangsu 212000,China)

机构地区：[1]镇江市药品不良反应监测中心,江苏镇江212000

出　　处：《医疗装备》2022年第7期30-32,共3页Medical Equipment

基　　金：镇江市社会发展指导性科技计划项目(FZ2020070)。

摘　　要：该研究通过对镇江市83家Ⅱ、Ⅲ类医疗器械生产企业的不良事件监测和再评价工作进行问卷调查,分析目前存在的问题,并从医疗器械上市许可持有人的视角提出建议,为其适应法规监管要求开展不良事件监测和再评价工作提供借鉴。This paper analyzed the existing problems through a questionnaire survey on the medical equipment adverse event monitoring and re-evaluation in 83 class-Ⅱ and class-Ⅲ medical equipment manufacturers in Zhenjiang,then put forward some suggestions from the perspective of medical equipment marketing authorization holders,which can provide references for them to carry out medical equipment adverse event monitoring and re-evaluation works to meet the requirements of regulations.

关 键 词：医疗器械上市许可持有人 不良事件监测 再评价 问卷调查 

分 类 号：R197.39[医药卫生—卫生事业管理]