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Russia - how the legal responsibilities are shared between the foreign manufacturer and the Russian company named on the registration certificate of medical devices

  • 1.  Russia - how the legal responsibilities are shared between the foreign manufacturer and the Russian company named on the registration certificate of medical devices

    Posted 12-Jul-2021 13:06
    Dear Colleagues,

    according to the current Russian law how the legal responsibilities are shared between the foreign manufacturer
    and the Russian company named on the registration certificate of medical devices
    Thank you. Cпасибо.

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    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
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  • 2.  RE: Russia - how the legal responsibilities are shared between the foreign manufacturer and the Russian company named on the registration certificate of medical devices

    Posted 13-Jul-2021 15:28
    Manufacturer (legal) is responsible for the device and everything that happens to it while it is curculating in Russia. Registration Certificate might be issued in the name of Legal Manufacturer or in the name of its Notified Representative. Every Manufacturer must have Notified Representative in Russia. It must be confirmed by Power of Attorney and this PoA will be submitted together with application. If Manufacturer doesn't have Notified Representative, then registration is not possible. Actually legal circulating of its devices is not possible too. Notified Representative must be specified on Labels and IFUs.

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    Oksana Kolosova
    Moscow
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    Original Message


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