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  • 1.  list of countries, where the condition of the Marketing Authorisations' issuance of medical devices is the validity of the relevant product's CE-certificate

    Posted 30-Jun-2021 10:03

    Dear Colleagues,


    what are the countries (beyond Australia and Israel) where issuance of a marketing authorisation (MA) requires valid CE-certificate?

    Loss of the CE-certificate automatically triggers the loss of the coupled MA in these countries?

    Thank you for sharing your opinion.

    regards



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    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
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  • 2.  RE: list of countries, where the condition of the Marketing Authorisations' issuance of medical devices is the validity of the relevant product's CE-certificate

    Posted 30-Jun-2021 18:23
    Hello Peter​

    There are several countries that offer a simplified registration pathway if you have a CE certificate or a 510(k), for example. Anywhere you actually submitted a CE certificate to support registration would probably care about the loss of the certification. I'm not aware of any other countries that take an interest.

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: list of countries, where the condition of the Marketing Authorisations' issuance of medical devices is the validity of the relevant product's CE-certificate

    Posted 03-Jul-2021 16:29
    As for former USSR countries, it might lead to loss of license in Ukraine (their authorization is directly linked to CE-certificate).
    As for Russia you would have to update your dossier for this Registration certificate. CE-certificate is not required to get registration in Russia, but any change of documents in the dossier must be submitted and (mostly) approved by regulator.
    In Kazakhstan now there is a simplfied procedure for registration of some MD that have CE-certificate, so losing one may lead to some questions from Regulatory Body and necessity to complete some additional local reviews.

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    Oksana Kolosova
    Moscow
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    Original Message


  • 4.  RE: list of countries, where the condition of the Marketing Authorisations' issuance of medical devices is the validity of the relevant product's CE-certificate

    Posted 06-Jul-2021 11:29
    Edited by Fajar Dumadi 06-Jul-2021 11:28
    Hi Peter,

    South Africa is also one of countries whose license validity impacted by CE certificate validity.

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    Fajar Dumadi
    Regulatory Intelligence Officer
    Vancouver BC
    Canada
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    Original Message


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