摘要
召回是医疗器械上市后监管的重要措施,能显著消除或减少缺陷医疗器械的风险和危害。我国医疗器械召回管理在法规制度、信息监测等方面与发达国家相比都存在很大差距,应借鉴国外医疗器械召回管理的有效经验。其中,加强对全球医疗器械召回信息的监测是重要途径之一。
It is important to recall the post-marketing defected medical devices to reduce or eliminate the possible risks and damage. Compared to the developed countries, there is biger gap about the recall regulations, signal monitoring ,et al. in China. We should learn the mature recall management from the foreign countries. It is significant to strengthen the monitoring of the global recall notices .
出处
《中国药物警戒》
2007年第6期332-334,共3页
Chinese Journal of Pharmacovigilance
关键词
召回
医疗器械
监测
recall
medical devices
monitoring
