上海市体外诊断试剂生产企业十年发展及监管情况回顾

Ten Years Review of the Development and Administration of Shanghai IVD Reagents

通过对上海市体外诊断试剂生产企业自2000年至2010年十年内企业和产品在数量、种类、规模、生产方式等方面的监管数据进行统计和分析,阐述了体外诊断试剂作为医疗器械特殊品种监管的历程及发展现状,旨在找出体外诊断试剂目前监管中存在的问题,提出未来监管的重点以及改进的建议。

This article reviews the development and administration of Shanghai IVDs（In Vitro Diagnostics） manufactures by analyzing the administration and history of the regulation of IVDs in ten years. It is to find out the problems in the administration of IVDs manufactures and products, and to make suggestions for improvements.