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2014年1月14日国家食品药品监督管理总局办公厅发布关于基因分析仪等3个产品分类界定的通知。为适应医疗器械监管工作需要,国家食品药品监督管理总局组织有关单位和专家对基因分析仪等3个产品的管理类别进行了界定。一、作为Ⅲ类医疗器械管理的产品(1个)基因分析仪:由移液模块、成像检测模块、数据处理模块及显示控制部分组成,通过对样本中DNA或RNA分析,检测人基因数量和序列的变化。本产品不用于全基因组测序。分类编码:6840。二、作为Ⅰ类医疗器械管理的产品(1个)
January 14, 2014 The General Office of the State Food and Drug Administration released a notice on the definition of the three product categories such as genetic analyzer. In order to meet the needs of regulatory work of medical devices, the State Food and Drug Administration organized the relevant units and experts to define the management categories of three products such as genetic analyzer. First, as a Class III medical device management products (1) Genetic analyzer: the pipetting module, imaging detection module, data processing module and display control part of the sample by DNA or RNA analysis to detect the number of human genes and Sequence changes. This product is not intended for whole genome sequencing. Category Code: 6840. Second, as a class I medical device management products (1)