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99项器械标准开始制修订

健康 来源:健康报 2018年08月10日 09:20 A-A+ 二维码
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原标题:

近日,国家药品监督管理局印发《2018年医疗器械行业标准制修订项目的通知》,公布今年开展制修订工作的99项医疗器械行业标准,其中包括“放射治疗用门控接口”等68个制定项目,“医用冷藏箱”等31个修订项目。

《通知》要求,医疗器械标准管理中心要严格按照《医疗器械标准管理办法》《医疗器械标准制修订工作管理规范》组织开展医疗器械行业标准制修订工作,加强制修订工作和经费管理,确保各项工作任务按要求完成。各标准制修订项目承担单位在制修订过程中要充分了解和掌握所涉及的主要产品情况,做好标准技术内容的验证工作。其中,对于修订的标准项目,要明确标准变化的内容,并对标准实施时间和注册等环节提出实施意见建议。(首席记者刘志勇)

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我要纠错编辑:邹杨 责任编辑:张福伟
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