摘要
该文对2013—2016年国家医疗器械抽检复检改判情况进行归纳、分析。通过整理国家医疗器械抽检不合格及受理复检的相关数据,总结出五种复检改判情况并以抽检实例进行说明,分析改判原因、发掘深层问题。同时针对复检改判研究所发现的各类问题,提出相应的解决建议。
The types and the reasons of changing the original test result after retesting in national medical device sampling and testing from 2013 to 2016, are summarized and analyzed. Firstly, collecting data of "standards not complied" and retesting. Then, giving specific examples when summarizing five types of changing the original test result after retesting. Meanwhile, analyzing the relevant reasons, discovering the deep problems. Finally, giving suggestions for the above problems.
出处
《中国医疗器械杂志》
2018年第1期56-57,69,共3页
Chinese Journal of Medical Instrumentation
关键词
医疗器械
抽检
复检
改判
medical device
sampling and testing
retesting
changing the original test result
