{"id":7184,"date":"2018-05-15T15:13:31","date_gmt":"2018-05-15T13:13:31","guid":{"rendered":"http:\/\/www.thema-med.com\/?page_id=7184"},"modified":"2025-03-27T09:20:55","modified_gmt":"2025-03-27T08:20:55","slug":"medical-device-registration-kazakhstan","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-kazakhstan\/","title":{"rendered":"Medical Device Registration in Kazakhstan"},"content":{"rendered":"
\"kazakistan\"<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

Ministry of Healthcare of the Republic of Kazakhstan<\/p>\n

Technical Support Agency<\/h2>\n

National Centre for Expertise of Drugs and Medical Devices (NCEDMD)<\/p>\n

Classification<\/strong><\/h5>\n

Class I, IIa, IIb, III<\/p>\n

Quality system<\/strong><\/h5>\n

ISO 13485:2016<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n

<\/p>\n<\/div>

<\/i><\/span>The information on this page is valid and current as of March 2025. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

In Kazakhstan, medical device registration can currently be carried out via two separate routes: the national system<\/strong> and the supranational system of the Eurasian Economic Union (EAEU)<\/strong>, of which Kazakhstan is a member along with Russia, Belarus, Armenia, and Kyrgyzstan.
Registration will only be possible through the EAEU system from January 1, 2027<\/strong>, which allows devices to be marketed in all member countries of the Eurasian Economic Union.<\/p>\n

Registration Procedure <\/span><\/h2>\n
    \n
  • National registration<\/strong><\/li>\n<\/ul>\n

    The application must be submitted electronically to the National Centre for Expertise of Drugs and Medical Devices<\/em> (NCEDMD), which is responsible for the technical evaluation of applications and the administration of any laboratory tests. Once the evaluation process has been completed, the certificate can be issued. <\/p>\n

      \n
    • EAEU Registration<\/strong><\/li>\n<\/ul>\n

      For the registration of a medical device, the applicant must choose a reference Member State and at least one involved Member State. The Applicant must select at least one of the Member States of the Eurasian Economic Union, which will be defined as the involved Member State, that will participate in the second step of the registration procedure to approve or reject the outcome of the decision made by the experts of the Reference State where the manufacturer intends to register the device.
      The application must be submitted via the EAEU electronic platform operated by the Eurasian Economic Commission<\/em> (EEC). The Ministry of Healthcare<\/em> remains the competent authority at the national level, while the NCEDMD<\/em> plays the role of technical support for documentation evaluations, and technical and clinical data review. In addition, a production site inspection (on-site verification) is provided for complex or innovative devices, or manufacturers at their first registration in the EAEU. The EAEU certificate issued is valid in all member countries of the Eurasian Economic Union.<\/p>\n

      Applicant<\/h2>\n
        \n
      • National Registration<\/strong><\/li>\n<\/ul>\n

        Non-Kazakh manufacturers must appoint an Authorised Representative based in Kazakhstan who is responsible for device registration and post-registration compliance.<\/p>\n

          \n
        • EAEU Registration<\/strong><\/li>\n<\/ul>\n

          Non-Kazakh manufacturers are obliged to appoint an Authorised Representative based in Kazakhstan or another EAEU country.<\/p>\n

          Timeframes<\/h2>\n
            \n
          • Registrazione Nazionale<\/strong><\/li>\n<\/ul>\n

            Dai 6 ai 12 mesi circa.<\/p>\n

              \n
            • Registrazione EAEU<\/strong><\/li>\n<\/ul>\n

              Dai 12 ai 24 mesi circa.<\/p>\n

              Validity<\/h2>\n
                \n
              • National registration<\/strong><\/li>\n<\/ul>\n

                5 years <\/p>\n

                  \n
                • EAEU Registration <\/strong><\/li>\n<\/ul>\n

                  Unlimited validity (unless there are regulatory changes or significant changes to the device). <\/p>\n

                  Documentation Language and Labelling<\/h2>\n
                    \n
                  • National and EAEU registration<\/strong><\/li>\n<\/ul>\n

                    Documentation: Russian.<\/p>\n

                    Labelling and IFU: Russian and Kazakh.<\/p>\n<\/p>\n

                    Useful Information<\/h2>\n

                    Possession of an EC certificate does not exempt one from registration under the EAEU system. However, technical documentation already prepared for CE marking can be partially re-used by adapting it to the specific EAEU requirements.<\/p>\n<\/div><\/div><\/div><\/div><\/div>

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                    <\/p>

                      <\/ul><\/div>\n
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                      \n<\/fieldset>\n

                      Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n