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NMPA Announcement on the Emergency Approval Procedure for Medical Devices

CCFDIE| Updated: 2021-12-29

In order to effectively prevent, timely control and eliminate the hazards of public health emergencies and ensure that the approval of medical devices required for emergency response to public health emergencies can be completed as soon as possible, according to the Regulations for the Supervision and Administration of Medical Devices (State Council Order No.739), Provisions for the Registration and Filing of Medical Devices(SAMR Order No.47) and Provisions for the Registration and Filing of In Vitro Diagnostic Reagents (SAMR Order No.48), National Medical Products Administration organized to revise the Emergency Approval Procedure for Medical Devices, which is issued and take effect as of December 29, 2021. The Notice on Printing and Issuing the Emergency Approval Procedure for Medical Devices issued by the former China Food and Drug Administration (CFDA [2009] No.565) shall be abolished at the same time.