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“日本ⅩX×”-环球时报

中新健康丨国家药日本ⅩX×监局发布国家医疗器械监督抽检结果

来源: 证券日报
2024-12-09 22:42:35

最佳回答

“日本ⅩX×”中新健康丨国家药日本ⅩX×监局发布国家医疗器械监督抽检结果

  中新日本ⅩX×网12月9日电 据国家药品监督日本ⅩX×管理局官方微信消息,为加强医疗器械监督管理,保障医疗器械产品质量安全有效,国家药品监督管理局组织对医用电动压缩式雾化器、牙科车针等6个品种进行了产品质量监督抽检,有10批(台)产品不符合标准规定。现将有关情况通告如下:

  一、 被抽检项目不符合标准规定的医疗器械产品

  (一) 医用电动压缩式雾化器3台:分别为东莞市健宝电子科技有限公司、佛山市顺德区键合电子有限公司、宁波吉丽医疗器械有限公司生产,涉及中位粒径不符合标准规定。

  (二) 医用脉搏血氧仪3台:分别为河南鑫磊峰医疗器械有限公司、河南友倍康医疗器械有限公司生产,涉及信号不完整性不符合标准规定。

  (三) 肢体加压理疗设备1台:元金物产株式会社/Wonjin Mulsan co.,Ltd.生产,涉及治疗压强(额定电压下)不符合标准规定。

  (四) 关节内窥镜1批:纳通生物科技(天津)有限公司生产,涉及综合光效不符合标准规定。

  (五) 牙科车针1批:Drendel + Zweiling DIAMANT GmbH 勃兰顿+兹威灵金刚砂有限公司生产,涉及尺寸不符合标准规定。

  (六) 肌酐测定试剂(盒)1批:上海捷门生物技术有限公司生产,涉及线性区间、准确度不符合标准规定。

  二、监管要求

  对抽检发现的不符合标准规定产品,国家药品监督管理局已要求企业所在地省级药品监督管理部门按照《医疗器械监督管理条例》《医疗器械生产监督管理办法》《医疗器械召回管理办法》等要求,及时作出行政处理决定并向社会公布。省级药品监督管理部门要督促企业对抽检不符合标准规定产品进行风险评估,根据医疗器械缺陷的严重程度确定召回级别,主动召回产品并公开召回信息;督促企业尽快查明产品不合格原因,制定整改措施并按期整改到位。

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