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  • 1.  "Swiss-Exit"

    This message was posted by a user wishing to remain anonymous
    Posted 19-Jan-2023 08:31
    This message was posted by a user wishing to remain anonymous

    Dear Switzerland Experts,

    Regarding the Swiss Medical Device situation, is there any more official news beyond what is written here?
    Switzerland eyes allowing FDA-approved medical devices onto its market

    We are based in the US. In 2022, we contracted with a CH REP to represent our CE marked products (which also have 510-k clearance). This service is not inexpensive.

    If we are no longer relying on CE Marking for Switzerland, is a CH REP is required to access the Swiss market going forward?

    Appreciate any insights.


  • 2.  RE: "Swiss-Exit"

    Posted 20-Jan-2023 05:39
    Dear Anonymous,
    Why would Switzerland deviate from this requirement?  What would justify not to have a local contact for the manufacturer.  Almost all other regulatory areas also require some sort of representative. 

    However, the law is not final and it has to be seen what Switzerland comes up with. 

    It was already communicated that it may take much longer to allow FDA cleared/approved products in Switzerland and may be if the EU gets its act together that it may not pass the Parliament at all.

    This is all chrystal ball reading.

    Please let me know whether the information is helpful.

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    Ludger Moeller
    President, MDSS GmbH
    l.moeller@mdssar.com
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    Original Message


  • 3.  RE: "Swiss-Exit"

    Posted 23-Jan-2023 12:28

    Hello Anonymous,

    We agree that most likely Swissmedic will keep the CH-REP requirement. Currently, Swissmedic puts a lot of responsibility on the Swiss rep. For example, the Swiss rep is responsible for safety-related matters for the device once placed on the Swiss market, e.g., vigilance reporting.

    It is unlikely that Swissmedic would require a CH-REP for CE marked devices, which their own regulation currently fully supports, but then not for FDA devices, where the classification scheme and regulatory filing are so different than in the EU/Switzerland. So, likely you will be committed to a CH-REP for as long as you stay on the market, whether leveraging your CE Marking, or eventually your FDA clearance/approval.

    Regarding the timing, there is no further news on that quite yet. It passed through Swiss Parliament last month and still needs to be put into law. Likely a draft proposal, then the final legislation after. We anticipate more information on this later in 2023.



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    Sydney O'Connell
    Director of Global Representation
    www.casusconsulting.com
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    Original Message


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