Guangdong Drug Administration

through Tell

2020Year32number

  according to Ministry of Commerce customs head office Announcement of the State Drug Administration on orderly export of medical materials Notice2020Year5number ,In order to comprehensively strengthen the epidemic prevention and control, the export quality supervision of medical devices,Effectively guarantee the quality and safety of exported medical devices,Combined with the current situation of epidemic prevention and control material supply in our province and the work deployment requirements of the State Food and drug administration,It is now decided to adjust the emergency approval of medical masks and other prevention and control products,Relevant requirements are notified as follows:

one since4month4From the day,No longer follow Notice of the office of Guangdong Drug Administration on printing and distributing medical masks Notice on Application guidelines for emergency approval of urgently needed equipment for epidemic prevention and control such as medical protective clothing Guangdong Drug Administration Office 2020 90number Accept the application for emergency approval in accordance with the provisions of.The registration application has been submitted to our bureau according to the emergency approval procedure and the materials meet the acceptance requirements,Follow the original procedure.

two Disposable medical masks have been obtained surgical mask Medical protective mask Medical protective clothing Infrared thermometer, etc5Of emergency Filing Certificate for category,A written application for emergency approval may be submitted to the Provincial Bureau,The Provincial Bureau shall organize the assessment and decide whether to incorporate it into the emergency approval procedure.

three Application for registration of medical devices with the above varieties not included in the emergency approval procedure during the epidemic period,All shall be handled according to the priority approval procedure.

four For those who have obtained emergency Filing Certificate,Medical device registration fee can be reduced or exempted when applying for registration.

five Class II medical device registration certificate issued in accordance with emergency approval procedures during the epidemic,Certificate validity1year,It is necessary to continue production at the expiration of the validity period,Shall expire on6Application for renewal of registration months ago.

Guangdong Drug Administration

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