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  • 1.  Requirement for Swiss AR?

    This message was posted by a user wishing to remain anonymous
    Posted 01-Jul-2022 10:11
    This message was posted by a user wishing to remain anonymous

    I find this forum to be very helpful so thank you in advance. 
    My question is the following: Since Switzerland has left the EU in order to sell directly to hospitals & clinics, is a Swiss AR now required?


  • 2.  RE: Requirement for Swiss AR?

    Posted 01-Jul-2022 21:57
    Yes, if the manufacturer is located outside Switzerland.  There is some explanation of responsibilities and timelines in this information sheet:
    https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/ch-rep.html

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    Anne LeBlanc
    United States
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    Original Message


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