Regulatory Open Forum

 View Only

  • 1.  Eurasian countries

    Posted 17-Aug-2022 16:42
    Dears,

    I would like to ask, are there countries outside the EEA that accept the CE mark (EU certification according to the MDR/IVDR) or according to the GHTF? Does the medical device with a CE mark also accept Kazakhstan or Eurasian countries in general? In other words, will a CE mark be enough to import a medical device into Kazakhstan?

    Thank you 

    Lukas

    ------------------------------
    Lukas Peter
    Ph.D.
    Hradec Králové
    Czech Republic
    ------------------------------


  • 2.  RE: Eurasian countries

    This message was posted by a user wishing to remain anonymous
    Posted 18-Aug-2022 09:08
    This message was posted by a user wishing to remain anonymous

    If you are asking about a Eurasia registration, when submitting an EACU registration, the RZN regulatory body did ask for a list of countries where the device is registered as well as country registration certificates obtained. The EU was one of the countries on the list and the IVDD DoC (general IVD) was submitted. It may help to go through the EACU regulation or reach out to one of the EACU countries regulatory bodies.
    Original Message


  • 3.  RE: Eurasian countries

    Posted 21-Aug-2022 20:03
    Hello,

    It depends on a country. If you are talking about EAEU (Eurasian) region, then there are 5 countries: Russia, Kazakhstan, Armenia, Belarus, Kyrgyzstan.
    All of them except for Armenia do have local registration requirements for MD. That means that you have to register your device there. For some devices you may need CE mark (meaning documents related to that actually), for some devices - you may not. 
    In Russia it is really irrelevant if you have a CE mark, BUT there is a lot of requirements that you have to fullfill, so most likely you if you fullfill them, then your device is eligible for CE mark as well. (RZN is Russian regulatory body).
    Kazakhstan does have local registration procedure, so having just CE mark is not enough. They even require manufacturing site inspection actually. It depends on your device etc. 
    Note that EAEU registration procedure is already implemented, however, you still can register your product locally in all mention above 5 countries. This possibility will be proloned up until 2025 (there is a draft of decree published on Thursday, and it should  be implemented shortly).
    EAEU procedure for MD is still very unclear, there are very few certificates issued, so you may consider local registration. EAEU registration will take you longer and clinical trial might be more expensive. If you are trying to get on KZ market, go for a local procedure. KZ local registration will cost you much cheaper and take less time than EAEU procedure.
    There are other countries (ex USSR): Georgia, Tadjikistan, Azerbaijan, Turkmenia, Uzbekistan. For those you will need or CE mark or FDA registration (shortly said). Uzbekistan and Turkmenia also have local registration for MD. 3 other countries do not.
    Hope that helps,
    Oksana


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

    Original Message


Related Content