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Mandatory requirements for placing a medical device into circulation within the Eurasian Economic Union include its registration and expert evaluation, which are conducted by the competent authority of the reference state. Identical requirements apply both to medical devices produced within the EAEU territory and to those imported from third countries into the customs territory of the Union. The registration procedure involves the issuance of official authorisation by the competent authority, granting the right to medical use and free circulation of the device across all EAEU member states.
Licensing of pharmaceutical activity is a mandatory procedure for implementation of activity related to the production, manufacturing, and sale of medicinal products and medical devices.
Medical devices (medical product, medical equipment), in accordance with the current legislation of the Republic of Kazakhstan, require mandatory state registration and obtaining a registration certificate. Registration gives the right to import, sell, and use the product throughout the territory of the Republic of Kazakhstan.
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