Regulatory Open Forum

 View Only

  • 1.  MEDICAL DEVICE REGISTRATION GEORGIA

    Posted 15-Jul-2022 09:04
    Hi, 

    Does anyone know if there is any registration procedure for medical devices in Georgia?

    I found information about importation/request of product classification through submission of a letter to the Ministry of Labor, Health and Social Affairs of Georgia, but I couldn't find any legislative reference about.

    Could you please help me finding this kind of information?

    Thank you very much in advance

    Best regards

    ------------------------------
    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
    ------------------------------


  • 2.  RE: MEDICAL DEVICE REGISTRATION GEORGIA

    Posted 18-Jul-2022 19:22
    Hello,

    There is no registration for MD in Georgia, except for in-vitro products and some dental products. Those are being registered similarly to medicines.
    A letter of classification from the Ministry might be useful in order to prove at Customs that your product is NOT a medicine and does not need a registration. MD will have to be certified when you import it - usually a company that imports it will be able to do it easily.
    Oksana


    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


  • 3.  RE: MEDICAL DEVICE REGISTRATION GEORGIA

    Posted 19-Jul-2022 02:42
    Hi, 
    thank you so much for the reply. Do you provide any regulatory reference or weblink about?

    ------------------------------
    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
    ------------------------------

    Original Message


  • 4.  RE: MEDICAL DEVICE REGISTRATION GEORGIA

    Posted 22-Jul-2022 16:01
    Hello, Valentina,

    I don't believe you will find this on Ministry's site.  You should note that this is not a Ministry of Health's regulatory requirement. This is rather Customs' recommendation. Moreover, officially you may not be obliged to provide such a letter, but it would be up to an importer how to prove that a device is a medical device, but not a medicine/drug.  Providing a letter would make things smooth. That's all. There are many things in CIS countries that are just "recommended", but if you don't do them, then your life/work becomes much more difficult.

    Oksana

    ------------------------------
    Oksana Kolosova
    Moscow
    ------------------------------

    Original Message


  • 5.  RE: MEDICAL DEVICE REGISTRATION GEORGIA

    Posted 25-Jul-2022 02:57
    Ok, really helpful!!

    Best regards

    ------------------------------
    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
    ------------------------------

    Original Message


  • 6.  RE: MEDICAL DEVICE REGISTRATION GEORGIA

    Posted 11-Aug-2022 07:36
    Medical devices are exempt from registration in Georgia per our distributor. (Class IIa medical devices).

    ------------------------------
    Hannes Hyvonen
    RA Manager at Icare Finland
    Vantaa
    Finland
    ------------------------------

    Original Message


Related Content