关于公开征求对免于临床试验体外诊断试剂目录的通知
发布时间：2024-11-05
各有关单位：
为贯彻落实中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号），进一步规范体外诊断试剂临床试验工作，扩大免于临床试验体外诊断试剂目录（以下简称体外诊断试剂豁免目录）范围，我中心启动了2024年度体外诊断试剂豁免目录的制修订工作。
在前期工作基础上，我中心形成了《免于临床试验体外诊断试剂目录（2024年征求意见稿）》（见附件1），即日起在中心网站公开征求意见。同时，也请各有关单位对2021年发布的体外诊断试剂豁免目录（国家药监局2021年第70号通告）提出建议新增和修订的意见。请填写意见反馈表（见附件2），于2024年12月3日前发送至邮箱：huangyl@cmde.org.cn。发送邮件时，请在邮件主题处注明“2024年体外诊断试剂豁免目录意见反馈”。
附件：1.建议新增和修订的免于临床试验体外诊断试剂目录（2024年征求意见稿）（下载）
2.豁免目录意见反馈表-IVD（下载）
国家药品监督管理局
医疗器械技术审评中心
2024年11月4日
业务咨询
客户意见反馈
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