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

北京市药品监督管理局关于印发《北京市医疗器械无菌包装封口过程确认检查要点指南(2023版)》的通知

2023-12-14 09:41:00source |

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京药监发〔2023〕276号

各区市场监管局,房山区燕山市场监管分局,市市场监管局机场分局,北京经济技术开发区管理委员会商务金融局,市药监局各分局,各相关事业单位:

  为深入贯彻落实医疗器械生产监管相关法规要求,进一步规范北京市医疗器械生产监督检查工作,持续强化医疗器械生产科学监管,市药监局组织对《无菌包装封口过程确认检查要点指南(2013版)》进行了修订,形成《北京市医疗器械无菌包装封口过程确认检查要点指南(2023版)》,现印发给你们,请参照执行。

  特此通知。

  北京市药品监督管理局

  2023年12月6日

  附件:北京市医疗器械无菌包装封口过程确认检查要点指南(2023版)