2015年4月28日,由国家食品药品监督管理总局医疗器械监管司举办的“体外诊断试剂使用单位开放日”活动在南昌大学第一附属医院举行。部分全国人大代表、政协委员,江西省人大代表、政协委员应邀参加了“开放日”活动。中国医疗器械行业协会、中国医药新闻信息协会、江西省和南昌市消费者协会代表,新华社、中国青年报、中国消费者报、中国医药报、医药经济报、中国网等10余家媒体记者,以及来自医院、社区和社会团体等代表参加了活动。总局医疗器械监管司有关负责人出席了活动。
本次“体外诊断试剂使用单位开放日”活动按照《食品药品监督管理总局办公厅关于印发体外诊断试剂质量评估和综合治理工作方案的通知》要求,以“体外诊断试剂使用、质量、安全”为主题,进一步加强体外诊断试剂使用单位与公众的沟通,增进公众对体外诊断试剂使用过程和质量管理的了解,引导社会各界对体外诊断试剂产品质量进行监督,推进社会共治格局的形成,进一步规范体外诊断试剂市场秩序,促进产业健康发展。
在活动中,代表们深入医院检验科、体外诊断试剂冷库等现场,观看了计算机管理信息系统以及相关检测项目的演示,听取了体外诊断试剂采购、入库质量验收、贮存养护、领用出库等环节的质量安全管理措施保障情况的介绍,增进了公众对体外诊断试剂的直观了解。随后,总局器械监管司组织代表们就体外诊断试剂的质量安全和使用监管等话题进行了座谈交流。代表们还分别就产业发展和监管能力提高等方面提出了建设性的意见和建议。
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