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《体外诊断试剂注册管理办法修正案》解读
作者: 信息来源:转载自国家总局网站 点击数:2007 更新时间:2017/2/10 10:44:15

  近日,国家食品药品监督管理总局公布了《体外诊断试剂注册管理办法修正案》,将《体外诊断试剂注册管理办法》(国家食品药品监督管理总局令第5号)第二十条第一款,由原“国家食品药品监督管理总局负责体外诊断试剂产品分类目录的制定和调整”,修改为:“本办法第十七条、第十八条、第十九条所述的体外诊断试剂分类规则,用于指导体外诊断试剂分类目录的制定和调整,以及确定新的体外诊断试剂的管理类别。国家食品药品监督管理总局可以根据体外诊断试剂的风险变化,对分类规则进行调整。”修正案自公布之日起施行。

  2014年,食品药品监管总局发布了《体外诊断试剂注册管理办法》,其中第十七条、第十八条、第十九条明确了体外诊断试剂分类规则,用于指导体外诊断试剂分类目录的制定和调整,以及确定新的体外诊断试剂的管理类别。

  近年来,随着体外诊断技术的发展、使用量的增加,按照《体外诊断试剂注册管理办法》第十七条、第十八条、第十九条对体外诊断试剂进行分类时,部分产品的分类与其风险不匹配,如对于肿瘤的诊断,免疫组化类体外诊断试剂检查结果只是为医生提供参考指标之一,医生还需要综合考虑其他大量诊断检测指标才能确诊,但按照上述条款,任何与肿瘤辅助诊断相关的体外诊断试剂均作为第三类医疗器械管理,分类不尽合理。由于上述条款内容缺少调整空间,使得相关产品类别调整与风险不匹配,不能适应医疗器械监管要求。

  本次修正案明确国家食品药品监督管理总局可以根据体外诊断试剂的风险变化,对分类规则进行调整,为将来分类规则和目录调整留出了空间。今后的工作中,国家食品药品监督管理总局将严格按照《医疗器械监督管理条例》的要求,以体外诊断试剂的风险为依据,在充分调研论证、公开征求意见的基础上,开展分类规则和目录的调整工作,使体外诊断试剂的管理类别划分更加科学、合理,进一步推进医疗器械审评审批改革,适应医疗器械产业发展需要以及临床使用和监管的要求。

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