摘要
针对目前已上市的自身免疫类体外诊断试剂产品所面临的问题进行了归纳及分析,并对此类产品在注册申报过程中应注意的问题提出了建议,以供制造商、监管者和临床使用单位参考。
In this paper,some significant problems,which were found frequently in the products of autoimmune in vitro diagnostic reagents,were summarized and analyzed in detail,and meanwhile a few relevant suggestions were put forward,which should be paid attention in the process of registration and application.
作者
付文竹
蔡瑶
徐加发
FU Wenzhu;CAI Yao;XU Jiafa(Center for Certification and Evaluation of Guangdong Drug Administration,Guangzhou,510080;Center for Certification and Evaluation of Jiangsu Food and Drug Administration,Nanjing,210002;Jiangsu Bioperfectus Technology Co.Ltd.,Taizhou,225300)
出处
《中国医疗器械杂志》
2021年第2期215-218,共4页
Chinese Journal of Medical Instrumentation
