The category of a product determines the research direction of the product's development pipeline;Therefore classification and definition establishments are important steps in the development of in vitro diagnostic reagent products.In recent years,the development of in vitro diagnostic reagent products has been rapidly advanced,with a large number of new products emerging continuously,which has also brought new challenges to the classification and definition work.The Medical Device Standards Management Center of the National Medical Products Administration regularly publishes the classification and definitions of medical devices,providing general guidance for enterprises.At the same time,the National Medical Products Administration has organized the revision of the updated version of the"In Vitro Diagnostic Reagent Classification Catalogue",which has made a lot of updates on the basis of the original 2013 version.How to improve the quality and efficiency of classification and definitions based on various documents issued by the National Medical Products Administration is a question worth considering.
关键词
体外诊断试剂/分类界定/审评监管/技术经验交流/案例分析
Key words
In vitro diagnostic reagents/Classification definition/Review and supervision/Technical experience exchange/Case analysis
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