Regulatory Open Forum

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  • 1.  Swiss and RoHS

    Posted 06-Mar-2022 22:02
    Dear Regulatory professionals,

    Currently, Switzerland is implementing their own medical device regulation, but could somebody advise us what they are doing in regard to the RoHS regulation?
    I suppose they will establish something equivalent but could you let us know the recent situation?

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    Soichiro Iida
    Kyoto
    Japan
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  • 2.  RE: Swiss and RoHS

    Posted 07-Mar-2022 00:55
    I found an explanation that Swiss already has a regulation which is in line with the RoHS but I could not find the name of that regulation. Could somebody advise us?

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    Soichiro Iida
    Kyoto
    Japan
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  • 3.  RE: Swiss and RoHS

    Posted 07-Mar-2022 01:21
    You can start here: https://www.fedlex.admin.ch/eli/cc/2020/552/en

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    Richard Jansky
    Head of RA / RM / QM
    Beringen
    Switzerland
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  • 4.  RE: Swiss and RoHS

    Posted 07-Mar-2022 04:56
    The Swiss Ordinance on the Reduction of Risks relating to the Use of Certain Particularly Dangerous Substances, Preparations and Articles (Chemical Risk Reduction Ordinance, ORRChem) SO 814.81 contains the implementation of RoHS 2 in Annex 2.18. This harmonizes Swiss regulation of hazardous substances in electrical and electronic equipment with the EU.

    https://www.fedlex.admin.ch/eli/cc/2005/478/en

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    Adrian Gammeter
    senior consultant
    Oberkirch
    Switzerland
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  • 5.  RE: Swiss and RoHS

    Posted 07-Mar-2022 18:27
    Dear Richard,
    Dear Adrian,

    Thank you so much for the valuable advices.
    They really helped us a lot!

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    Soichiro Iida
    Kyoto
    Japan
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