Regulatory Open Forum

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  • 1.  Ukraine Registration?

    Posted 24-Jun-2022 08:46
    A doctor in Ukraine contacted us last week, asking us to sell our device in his country. My CEO asked me to look into it, especially with everything going on over there.

    Does anyone have any insight into whether medical device registrations are ongoing right now? Or does anyone have any suggestions for ARs in Ukraine? Our existing EU AR doesn't have representation services there.

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    Kimberly Chan
    Lansdale PA
    United States
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  • 2.  RE: Ukraine Registration?

    Posted 24-Jun-2022 09:05
    I don't have insight in medical devices in Ukraine, but for drugs, Ukraine will currently approve any drug product that is approved for marketing in any other country without undergoing formal review by the Ukraine regulatory authority. So, if a manufacturer has marketing authorization in EMA or FDA for a drug product and has the possibility to import and distribute in Ukraine, they can apply and get very rapid approval.

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


  • 3.  RE: Ukraine Registration?

    Posted 25-Jun-2022 11:18

    Hi Kimberly,
    We are currently working on registering our devices in Ukraine.
    By the looks of it they are all back and it's business as usual!I will discuss with my colleague that is responsible for Ukrainian registrations on Monday and I will touch base again with more details. 



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    Dimitrios Samandis Tsolekas
    Lausanne
    Switzerland
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    Original Message


  • 4.  RE: Ukraine Registration?

    Posted 27-Jun-2022 08:41
    We are completing medical device registrations in Ukraine this month.  The consultant working on the matter insists things are proceeding regardless of what we hear in the "news" regarding the war and they have been pressing us to finish our submissions promptly.  I had expected this to go on the back burner but apparently not.

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    Maureen Miller
    General Counsel & RA Director
    Lake St Louis MO
    United States
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    Original Message


  • 5.  RE: Ukraine Registration?

    Posted 27-Jun-2022 18:20
    Hi Kimberly,
    Neither FedEx nor DHL are delivering to Ukraine, so the  requirement for legalized documents is being fulfilled by scanned copies, the originals to be held until otherwise advised.

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    Connie Dominguez RAC
    Owner and Founder; Regulatory Language Matters, LLC
    Tempe AZ
    United States
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    Original Message


  • 6.  RE: Ukraine Registration?

    Posted 01-Jul-2022 12:28
    Thanks so much everyone for your responses! Does anyone have a suggestion for an AR they have been working with whom they like?

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    Kimberly Chan
    Lansdale PA
    United States
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    Original Message


  • 7.  RE: Ukraine Registration?

    Posted 07-Jul-2022 13:49
    I believe they are ongoing yes. We actually just went through the routine annual Ukraine audit by the authorities.

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    Hannes Hyvonen
    RA Manager at Icare Finland
    Vantaa
    Finland
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    Original Message


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