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我国医疗器械监管法规的现状与发展 被引量:10

Studying the status of regulations on supervising medical devices and its development in China
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摘要 当前,医疗器械监管法规正处于内容修订和体系重构的重要时刻。一方面,医疗器械监管法规在获得较大立法进展的同时,仍然受困于固有的几大问题。另一方面,医疗器械监管法规又面临较多的发展机遇,其发展应该定位于更高级的法律阶位、更及时的法律创新、更严格的法律责任和更科学地接轨国际等四个方面。 Currently,supervision regulations for medical devices is facing the vitally point of revising contents and reconstructing system.On the one hand,it is still trapped in several inherent problems with great progress on legislation.On the other hand,it is also faced with many opportunities to develop,which should be positioned in some aspects as higher level,more timely legal innovation,more strict legal liability and more adaptive reference to international regulations.
作者 蒋海洪
出处 《中国卫生事业管理》 北大核心 2011年第5期364-365,380,共3页 Chinese Health Service Management
基金 上海市教育委员会选拔培养优秀青年教师科研专项基金资助项目(项目编号:slg08037)
关键词 医疗器械 监管法规 现状 发展 medical device supervision regulation status development.
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