关于上海市体外诊断试剂产业高质量创新发展的思考  

Thoughts on High-Quality Innovation and Development of in Vitro Diagnostic Reagents Industry in Shanghai

作　　者：梁爽 孙果梅 LIANG Shuang;SUN Guomei(Shanghai Medical Device and Cosmetics Evaluation and Verification Center,Shanghai,200020)

机构地区：[1]上海市医疗器械化妆品审评核查中心,上海市200020

出　　处：《中国医疗器械杂志》2024年第3期339-342,共4页Chinese Journal of Medical Instrumentation

摘　　要：体外诊断(in vitro diagnostic,IVD)试剂作为大健康产业的重要一环,在疾病的预防、诊断、治疗等方面发挥着至关重要的作用。近年来,特别是新型冠状病毒感染发生后,我国IVD产业发展迅速,但仍不能满足临床诊疗的需求。通过桌面研究、专家访谈、生产企业和医院调研等形式开展研究,分析了上海市体外诊断试剂产业发展的现状,从原材料、创新能力、临床试验等方面总结了行业高质量发展面临的问题,并提出促进本市体外诊断试剂产业高质量创新发展的参考建议。As an important part of the Big Health Industry,in vitro diagnostic(IVD)reagents play a vital role in the prevention,diagnosis and treatment of diseases.In recent years,especially after the novel coronavirus infection,IVD industry has developed rapidly in China,but it still cannot meet the needs of clinical use.By conducting desk research,expert interview,manufacturer survey and hospital survey,this study analyzed the development status of IVD industry in Shanghai,summarized the problems encountered in the highquality development from the aspects of raw materials,innovation ability,and clinical trials,etc.,and proposed recommendations for promoting the high-quality innovation and development of IVD industry in Shanghai.

关 键 词：体外诊断试剂 产业 创新发展 

分 类 号：R197.39[医药卫生—卫生事业管理]