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Registration and expert examination of a medical device are mandatory conditions for its release into circulation within the Eurasian Economic Union and are carried out by the authorised body of the reference state. At the same time, the same requirements apply to medical devices manufactured within the territory of the Eurasian Economic Union and medical devices imported into the customs territory of the Eurasian Economic Union from third countries. Registration of medical devices is a procedure for issuing permission by the authorised body for medical use and circulation of a medical device within the Eurasian Economic Union.
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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