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  • 1.  Swiss AR

    This message was posted by a user wishing to remain anonymous
    Posted 25-Aug-2021 16:57
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Due to Switzerland being treated as a 3rd country--what are the requirements of the Swiss AR? Does a company's distributor (located in Switzerland) have the ability to become the Swiss AR as well?

    Thanks!


  • 2.  RE: Swiss AR

    Posted 26-Aug-2021 03:48

    Dear Anon

    Of course, the distributor can become the Swiss AR. But he has to fulfil the additional requirements of the AR. You can find more information under this link. And don't forget, you will need also a Swiss importer.



    ------------------------------
    Oscar Banz
    RA & VIG Manager
    Grenchen
    Switzerland
    ------------------------------

    Original Message


  • 3.  RE: Swiss AR

    This message was posted by a user wishing to remain anonymous
    Posted 28-Aug-2021 00:25
    This message was posted by a user wishing to remain anonymous

    We have been cautioned (by our Swiss distributor, actually!) that using a distributor to fulfill this role may not be the best path. You will need to share your technical documentation with the CH AR, and most companies do not want to share this proprietary information with a distributor who could also be distributing competing devices. There is a workaround, but it involves sending your technical documentation directly to Swissmedic for review – which also has the potential to lead to more questions. 

    I think finding a CH AR who is not your distributor is preferable. If you are already selling in the EU, see if your EUAR is offering this service – many are adding it as an option, with the benefit that they likely won't need to re-review your technical documentation (except for CH-specific requirements) since they already represent you. 

    I'm really hoping Switzerland figures this out soon! Has anyone heard whether discussions are ongoing, or whether a resolution is expected?
    Original Message


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