ABOUT US

The Zhongguancun Shuimu Medical Technology Service Group was established in 2017 and is headquartered in the Beijing Yizhuang Economic and Technological Development Zone. It is committed to accelerating the process of registration and listing of innovative medical device products, and solving the "last mile" problem of industrialization for innovative medical device companies. The Group is the chairman unit of the Clinical Trial Branch of the China Association for Medical Devices Industry, the executive vice chairman unit of the Application Evaluation Branch of the China Medical Equipment Association, and the chairman unit of the Medical Device Committee of the Beijing Pharmaceutical Association.

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Shumuk University

国家药监局器审中心关于发布体外膜氧合(ECMO)循环套包动物试验注册审查指导原则的通告(2023年第39号)

2023-12-12 16:14:00source |

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为进一步规范体外膜氧合(ECMO)循环套包动物试验的管理,国家药监局器审中心组织制定了《体外膜氧合(ECMO)循环套包动物试验注册审查指导原则》,现予发布。

  特此通告。


  附件:体外膜氧合(ECMO)循环套包动物试验注册审查指导原则(下载


国家药品监督管理局

医疗器械技术审评中心

2023年12月5日