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Russia Registration for Medical Devices

Discussion in 'Other Medical Device Regulations World-Wide' started by fialor, Sep 6, 2016.

  1. fialor

    fialor Member

    Aug 30, 2016
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    Hi All,
    My company is in the process of registering a medical device in Russia and the distributor/partner is asking for essentially the entire "receipe book" for the device. I have been advised by the distributor that this is due to the rules for registration changing this year (2016) in Russia.

    I have registered devices in Russia before without the level of detail being requested now and this makes me nervous.

    Any one had experience of registering in Russia recently and have the supplier, material type and grade levels, name and location of manufacturer being requested?

    Any help at all would be welcome.