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各相关单位和个人：
根据全国医疗器械临床评价标准化技术归口单位2022年关于标准制定的工作安排，我标准化技术归口单位已完成《医疗器械临床评价-术语和定义》《体外诊断试剂临床试验-术语和定义》2项行业标准征求意见稿等相关材料，建议上述2项标准发布12个月后实施，现面向社会公开征求意见。
请相关单位组织人员对标准征求意见稿、编制说明（附件1-2）和建议实施日期提出意见或建议，填写《医疗器械标准征求意见反馈表》（附件3），于2022年10月8日前以电子邮件形式反馈至秘书处邮箱，邮件主题请注明标准名称。无意见也请邮件反馈说明。逾期未回复，视为无意见。
秘书处联系方式：
联系人：刘露（医疗器械）
电话： 010-86452501
邮箱： liulu@cmde.org.cn
联系人：何静云(体外诊断试剂)
电话：010-86452544
邮箱：hejy@cmde.org.cn
附件：1.《医疗器械临床评价-术语和定义》(征求意见稿)及编制说明
2.《体外诊断试剂临床试验-术语和定义》(征求意见稿)及编制说明
3.医疗器械标准征求意见反馈表
全国医疗器械临床评价标准化技术归口单位
2022年8月10日
【附件1】
《医疗器械临床评价-术语和定义》(征求意见稿)及编制说明
【附件2】
《体外诊断试剂临床试验-术语和定义》(征求意见稿)及编制说明
【附件3】
医疗器械标准征求意见反馈表
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