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15号）20240416
发布时间：2024-04-16
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，发现广东和信健康科技有限公司申报注册的呼吸道合胞病毒、甲型流感病毒、乙型流感病毒、腺病毒抗原联合检测试剂盒（流式细胞仪法-FITC/PE/Cy5/PC7）（受理号：CSZ2100014）存在临床试验真实性问题。该临床试验318例样本临床试验数据汇总表检测时间与原始仪器记录检测时间不一致，临床试验总结报告病毒鉴定结果数据与原始文件不一致。
根据《中华人民共和国行政许可法》第七十八条和《体外诊断试剂注册管理办法》第四十九条规定，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4月15日
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