To register a device it is necessary to submit the registration documents in electronic format (including the registration fee payment receipt), translated into Russian, at the National Center for the Expertise of Drugs and Medical Devices which will review the documentation.
The latter will carry out a detailed examination through a primary, analytical analysis (only for some devices) and a special analysis of the documentation and sample of the device submitted.
An inspection is planned by the Regulatory Authority to the manufacturer in case of device first placing on the market and devices requiring special installation and maintenance conditions (MRI, X-Ray).
In case of a successful outcome, a registration certificate will be issued and within ten days the approved instructions for use of the device and medical equipment in Russian and national language will be delivered, as well as approved packaging and labelling design.
Registered Medical Devices are posted on the National Center for Expertise of Drugs and Medical Devices web page.
Manufacturer or Local Authorized Representative.
Timeframe and fees
Registration timeframes vary from 4 months for Class I devices to 10 months for Class III devices.
The registration certificate has a duration of 5 years for Medical Devices, whereas for medical equipment it is valid for 7 years.
Labelling and documentation language
All documents must be in Russian, IFU must be both in Russian and Kazakh.
The applicant must submit the application for the registration renewal before the expiry date of the certificate or at least within six months after the registration expires.
Kazakhstan is part of the Eurasian Economic Union (EAEU) like Armenia, Russia, Kyrgyzstan and Belarus, therefore only Medical Devices complying with the approved Technical Regulations may be marketed.