国家药品监督管理局办公室公开征求《医疗器械临床试验检查要点及判定原则（征求意见稿）》意见
为强化对医疗器械临床试验过程的监督管理，有效开展医疗器械临床试验监督检查，国家药品监督管理局按照《医疗器械临床试验质量管理规范》《体外诊断试剂临床试验技术指导原则》的要求，组织起草了《医疗器械临床试验检查要点及判定原则（征求意见稿）》，现公开征求意见。
请将意见建议于2018年6月30日前以电子邮件形式反馈至国家食品药品监督管理总局食品药品审核查验中心。
联系人：周失、程锦
电 话：010-68441563、010-88331453
电子邮箱：zhous@cfdi.org.cn
附件：医疗器械临床试验检查要点及判定原则（征求意见稿）（下载）
国家药品监督管理局办公室
2018年5月31日
扫描下方的二维码订阅“CIRS医械合规动态”！实时传递最新医疗器械监管法规动态，分享医疗器械注册成功经验及经典案例跟踪医疗器械最新产品安全与法规监管动态，获得最新一手资讯。
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