国家药监局关于医疗器械临床试验监督抽查情况的通告（2024年第3号）2440108
发布时间：2024-01-08
为贯彻落实《医疗器械监督管理条例》，加强医疗器械临床试验监督管理，国家药品监督管理局组织开展医疗器械注册申请项目临床试验监督抽查，发现维泰医疗科技（常州）有限公司申报注册的外周药物（紫杉醇）涂层球囊导管（受理号：CQZ2200024）存在临床试验产品真实性问题。该产品注册检验报告中显示的收样日期早于生产设备和检验设备购进日期，注册检验报告所用检验产品不是由该公司生产。
根据《中华人民共和国行政许可法》第七十八条和《医疗器械注册与备案管理办法》第五十九条规定，对该注册申请项目不予注册，并自不予注册之日起一年内不予再次受理该项目的注册申请。
特此通告。
国家药监局
2024年1月5日
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