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为了加强体外诊断试剂经营企业的监督管理,规范其经营行为,国家食品药品监督管理局在2007年5月下发了《关于印发体外诊断试剂经营企业(批发)验收标准和开办申请程序的通知》(以下简称《通知》),要求新开办的体外诊断试剂经营企业以及换证企业必须设置冷库且不得小于20立方米,
In order to strengthen the supervision and management of in-vitro diagnostic reagents enterprises and regulate their business operations, the SFDA issued a Notice on Printing and Distributing the Acceptance Standards for IVD Enterprises (Wholesale) and Starting Application Procedure in May 2007. (Hereinafter referred to as the “Notice”) requires that the newly-started IV diagnostic reagent management enterprises and the replacement enterprises must set up cold storage and shall not be less than 20 cubic meters,