关于调整《6840体外诊断试剂分类子目录（2013版）》部分内容的公告（2020年 第112号）20201020
为进一步深化医疗器械审评审批制度改革，依据医疗器械产业发展和监管工作实际，按照《医疗器械监督管理条例》有关要求，国家药监局决定对《6840体外诊断试剂分类子目录（2013版）》进行调整。现将有关事项公告如下：
一、调整内容
对《6840体外诊断试剂分类子目录》中产品类别为III-7与肿瘤标志物相关试剂的部分体外诊断试剂管理类别及预期用途进行调整，具体调整内容见附件。
二、实施要求
（一）自本公告发布之日起，药品监督管理部门依据《体外诊断试剂注册管理办法》《体外诊断试剂注册管理办法修正案》《关于公布体外诊断试剂注册申报资料要求和批准证明文件格式的公告》，按照调整后的类别受理体外诊断试剂注册，进行审评审批。
（二）对于已受理尚未完成注册审批的体外诊断试剂，药品监督管理部门继续按照原受理类别审评审批，准予注册的，核发医疗器械注册证，并在注册证备注栏注明调整后的产品管理类别。
（三）对于已注册的体外诊断试剂，其管理类别由高类别调整为低类别的，在有效期内的医疗器械注册证继续有效。
如需延续的，注册人应当在医疗器械注册证有效期届满6个月前，按照改变后的类别向相应药品监督管理部门申请延续注册，准予延续注册的，按照调整后的产品管理类别核发医疗器械注册证。
（四）医疗器械注册证有效期内发生注册变更的，注册人应当向原注册部门申请注册变更。
（五）各省级药品监督管理部门要加强《6840体外诊断试剂分类子目录（2013版）》类别调整的宣贯培训，切实做好相关产品审评审批和上市后监管工作。
本公告自发布之日起实施。
附件：6840体外诊断试剂分类子目录部分内容调整表
国家药监局
2020年10月10日
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