江西省医疗器械监督抽检工作现状及对策研究

Sampling and Testing of Medical Devices in Jiangxi:Current Situation and Strategies

本文对江西省2019~2020年医疗器械监督抽检的现状进行了回顾和总结,分析了抽检工作中存在靶向性不强、医疗器械检测能力有待提升、样品复检率高及数据信息利用率不高等问题。针对抽检过程中出现的问题提出了可行性建议,以期为提高医疗器械质量监督抽检工作效率及监管效能提供参考。

This paper reviews and summarizes the current situation of medical device sampling and testing in Jiangxi from 2019 to 2020.A number of problems with sampling and testing are analyzed,including the lack of focus,inadequate medical device testing capability,relatively high rate of re-testing,insufficient use of data,etc.To tackle these problems,solutions are proposed for improving the efficiency of medical device sampling and testing and of medical device supervision.