我国体外诊断试剂质量现状分析

通过对国家食品药品监督管理局市场监督办公室提供的《各省医疗机构使用体外诊断试剂调查表》和《2009试剂生产(总代)调查表汇总》中II-11类(用于其他生理、生化或免疫功能指标检测的试剂)产品的生产现状、使用现状、监督检验、产品质量存在问题的初步分析,并结合实地调研情况,发现目前我国体外诊断试剂生产存在地域差异,各级医疗机构使用不平衡,没有一个系统完整的国家标准和行业标准,仍然存在分类标准不统一,生产企业和监督检验机构在产品注册或重新注册过程中重复操作等情况。因此,体外诊断试剂分类标准亟待统一,希望国家标准和行业标准能够早日发布。

Analysis of in Vitro Diagnostic Products (IVD) Actual Quality of China

We draw some conclusions that IVD production is vary from areas,usage is imbalanced from different grades hospitals and there are still no integrated state and industry standards of IVD in China,class criterion is complex,repeat operations exist in products registration and re-registration between manufactures and supervision or inspection institutions through questionaries of usage and production of IVD for each province(2009) offered by market supervision office of SFDA.Class criterion of IVD needs to be ...