甘肃省医疗器械生产企业自检状况和建议  

Self Inspection Status and Suggestions for Medical Device Manufacturing Enterprises in Gansu Province

作　　者：杨英 刘永鹏 李萍 路莉 方雪梅 YANG Ying;LIU Yong-peng;LI Ping;LU Li;FANG Xue-mei(Gansu Medical Device Inspection and Testing Institute,Gansu Lanzhou 730000)

机构地区：[1]甘肃省医疗器械检验检测所,甘肃兰州730000

出　　处：《中国医疗器械信息》2024年第15期7-9,共3页China Medical Device Information

摘　　要：目前,甘肃省医疗器械市场体量不大,生产企业数量少、经营类企业规模小,技术创新和产品复制、研发能力都偏弱,科研人才和技术劳动力缺乏。为有效提升省内医疗器械生产企业检验检测能力,全面加强医疗器械质量管理,省器械所依据医疗器械相关法律法规、规章、标准和规范性文件,结合本省医疗器械生产实际,在2023年对全省医疗器械生产企业开展检验检测能力的相关调研。调研组对武威、金昌、天水、陇南、白银、临夏州、兰州及兰州新区相关医疗器械生产企业,采取实地查看、现场询问、查阅检验报告、产品技术要求及体系文件的方式开展调研工作,并结合实际提出了加强企业自检能力的建议。At present,the medical device market in Gansu Province is not large,with a small number of production enterprises and a small scale of operating enterprises.The technological innovation,product replication,and research and development capabilities are weak,and there is a lack of scientific research talents and technical labor.In order to effectively improve the inspection and testing capabilities of medical device production enterprises in the province and comprehensively strengthen the quality management of medical devices,the Provincial Medical Device Institute follows relevant laws,regulations,standards,and normative documents related to medical devices,Based on the actual production of medical devices in our province,in 2023,a survey was conducted on the inspection and testing capabilities of medical device production enterprises in the province.The research team conducted research on medical device production enterprises in Wuwei,Jinchang,Tianshui,Longnan,Baiyin,Linxia Prefecture,Lanzhou,and Lanzhou New Area through on-site inspections,inquiries,inspection reports,product technical requirements,and system documents,and suggestions were put forward to strengthen the self inspection ability of enterprises based on actual situations.

关 键 词：医疗器械 自检 建议 

分 类 号：R197.39[医药卫生—卫生事业管理]