摘要
目的研究国内基层医疗器械监管现状,深入剖析医疗器械监管中存在的问题。方法提出改进基层医疗器械监管的建议和对策。结果与结论加强医疗器械上市后监管,开展不良事件监测和产品再评价,建立医疗器械召回制度,提高技术监督支撑能力,加强医疗器械监管队伍建设,加快立法步伐,才能保证公众用械安全有效。
Objective To study the status of the domestic primary supervision of medical device, in- depthly analyze medical device supervision problems. Methods Put forward to proposals and countermeasures for improving primary medical device regulatory. Results and Conclusions To enhance the supervision of medical devices of post-market and conduct monitoring of adverse events and product re- evaluation, establish recall system of medical device, improve support ability of technical supervision, strengthen the supervision team-building of medical devices and speed up the pace of legislation in order to ensure public safety and effective use of medical devices.
出处
《中国药事》
CAS
2009年第11期1053-1055,共3页
Chinese Pharmaceutical Affairs
关键词
医疗器械
监管
现状
对策
medical devices
supervision
the status quo
countermeasures
