加强医疗器械监督管理规范医疗器械检验操作

随着国家对医疗器械监管力度的加大,依法开展对医疗器械的监督检验,规范医疗器械检验机构的技术检验工作越来越重要。为顺应这一需要,我所组织编写了《医疗器械检验操作规范》,本文介绍了编写的背景及进展情况。

Enhancing the Management of Medical Device and Regulating the Operation

With the strengthened supervision and administration on medical devices, it becomes more and more important to carry out supervision test on medical devices in according with the law and to regulate the technical testing procedure of medical device testing institutions. To meet this need, our institute organizes the compilation of "standard operation procedure for medical device testing", and this article introduces the background and progress.