目的调查研究各国对于体外诊断试剂的分类管理模式,以及目前国内分类现状,在此基础上对全国目前有效注册产品信息进行汇总分析归纳,编制较为详细的体外诊断试剂分类目录,以指导试剂产品的分类,统一全国注册审查标准和审查尺度,有利于体外诊断试剂产品行业的规范发展。方法课题组历时一年,对全国2011年6月之前取得医疗器械注册证书,且在国家食品药品监督管理局网站公布有效的体外诊断试剂产品信息进行了汇总整理,按照生化、免疫、分子生物、微生物、血液等专业分为五个小组,在目录修订过程中充分借助专家力量、广泛征求意见,共组织召开12次专家讨论会,向11个省级药监部门及数十家医疗器械生产企业征求了意见,确保了修订后目录的适用性。结果课题组对国家食品药品监督管理局、北京市药监局以及其余地方局审批有效的产品信息共1.58万余条进行了逐条梳理、整合和排列,并补充了管理类别、产品分类、产品分类名称、预期用途等内容。于2012年6月形成分类目录的报批稿并在国家食药监局网站公布以征求意见。结论体外诊断试剂分类子目录的编制工作不单是产品的简单划分,还是开展监管工作的基础。该目录的出台为规范体外诊断试剂产品的分类、解决管理类别混乱的现象、统一全国的注册审查要求具有重要意义。 Objective To investigate the classification management mode of in vitro diagnostic reagents in various countries and the current status of the classification in China. Based on this, the author summarizes and summarizes the information of currently valid registered products in the country and draws up a more detailed catalog of in vitro diagnostic reagents to guide the reagent products Classification, unified national registration review standards and review standards, is conducive to the standardization of IVD reagent products industry. Methods The research group lasted one year, obtained the certificate of registration of medical devices before June 2011 and published the valid product information of in vitro diagnostic reagents on the website of the State Food and Drug Administration. According to the biochemistry, immunology, molecular biology, Microbiology, blood and other professional is divided into five groups, full use of expert power in the directory revision process, extensive solicitation of opinions, organized a total of 12 expert seminars, to 11 provincial drug regulatory departments and dozens of medical device manufacturers The comments were sought to ensure the applicability of the revised catalog. Results The research team conducted a total of more than 15,800 pieces of valid product information approved and approved by the State Food and Drug Administration, Beijing Food and Drug Administration and the rest of the local bureaus, sorted out, arranged and arranged one by one, supplemented management categories, product categories, product categories Name, intended use and so on. In June 2012, a draft for approval of the taxonomy was formed and posted on the State Food and Drug Administration website for comments. Conclusion The preparation of in vitro diagnostic reagents classification sub-directories is not only a simple division of products, but also the basis for regulatory work. The introduction of the catalog to regulate the classification of in vitro diagnostic reagents products to resolve the phenomenon of chaos in management categories, unified national registration examination requirements of great significance.