医疗器械法规变化解读

Comment about Medical Device Regulations' Amending

我国的医疗器械监督管理部门结合多年来的监管经验对目前的一系列医疗器械规章文件进行了相应的修订、调整,这些规章文件对于我国医疗器械监管工作将产生深远影响。本文通过介绍法规变化背景,分析法规变化特点,指出了我国医疗器械监管工作今后的发展趋势和医疗器械企业的应对措施。文章的最后对未来我国的医疗器械监管体系进行了展望。

With several years' experience of administrating Chinese medical devices' administration has amended a series of medical devices' regulations. These regulations will affect medical devices' administrating work fully. The paper introduces the background of regulations' amending and analyzes characteristic, points out the trend in administrating work's future and response measure of medical device enterprises. In the end of the paper, the prospect of medical devices' administrating system is provided.