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国家食药监总局发布红外乳腺检查仪等3项注册技术审查指导原则

2017-09-14 09:17:23   中国经济网

经济日报-中国经济网北京9月14日讯 记者从国家食品药品监督管理总局获悉,为加强医疗器械产品注册工作的监督和指导,进一步提高注册审查质量,国家食品药品监督管理总局组织制定了《红外乳腺检查仪注册技术审查指导原则(2017年修订版)》《医用臭氧妇科治疗仪注册技术审查指导原则(2017年修订版)》《骨组织手术设备注册技术审查指导原则(2017年修订版)》。

其中,《红外乳腺检查仪注册技术审查指导原则(2017年修订版)》对产品名称要求,产品的结构和组成,产品工作原理/作用机理,注册单元划分的原则和实例,产品适用的相关标准,产品的适用范围/预期用途、禁忌症,产品的主要风险及研究要求,产品技术要求应包括的主要性能指标,同一注册单元内注册检验代表产品确定原则和实例,产品生产制造相关要求,产品的临床评价细化要求,产品的不良事件历史记录,产品说明书和标签要求等十三个方面做出要求。

相关链接: 总局关于发布红外乳腺检查仪等3项注册技术审查指导原则的通告(2017年第146号)

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