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  • 1.  In Vitro Companion Diagnostic (CDx) Registration in Russia

    Posted 12-Aug-2015 13:18

    Does anyone have experience with the registration/submission requirements of an In Vitro Companion Diagnostics (CDx) system in Russia? Our CDx is comprised of a diagnostic device that provides information for the safe and effective use of a corresponding therapeutic drug.

    Is there a source to find English translated documents required by the Russian Department of Registration of Foreign Medical Equipment and Devices necessary for registration of CDx products specifically?

    Since we wish to use a legal entity of one of the Customs Union countries to act as our in-country representative to advise us and represent us in face-to-face meetings with the Russian authorities, does anyone have experience with companies who supply such services or know of a reference website?

    Do you think that the upcoming new EU regulations for IVDs addresses CDx systems and if so, is it expected to have an potential impact in Russia?

     Thanks for your help

    -----------------------------

    Robert Wilkinson
    President
    Resolute Regulatory Affairs Consulting Service, Inc
    Port Barrington IL
    United States
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  • 2.  RE: In Vitro Companion Diagnostic (CDx) Registration in Russia

    Posted 14-Aug-2015 18:26

    Hi Robert,

    The new medical device/IVD regulations in Russia have already been released so I doubt if they will be impacted by the upcoming EU regulations. The requirements for CDx registration in Russia are not very transparent right now, but there are a number of companies that are going through the process with the Russian Authority so the best thing to do is request an early face-to-face meeting with the Russian Authority.  

    You can obtain some of the regulations/guidance documents in English from the Emergo group website and some from this link:

    http://en.imeda.ru/legislation/

    Kind regards,

    ------------------------------
    Maham Ansari MS, RAC
    Associate Director, Regulatory Affairs
    Focal Healthcare
    Toronto ON
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    Original Message


  • 3.  RE: In Vitro Companion Diagnostic (CDx) Registration in Russia

    Posted 15-Aug-2015 08:44

    Maham,

    Thank you for the IMEDA website for English version of some in vitro Russian documents, it was very helpful.

    ------------------------------
    Robert Wilkinson
    President
    Resolute Regulatory Affairs Consulting Service, Inc
    Port Barrington IL
    United States
    ------------------------------


    Original Message