Medical Device Registration and Approval in Kazakhstan
General country-specific regulatory information is provided on this page for medical device registration and approval in Kazakhstan.
Last updated on November 29th, 2021.
Medical Device Regulations and Classification in Kazakhstan
REGULATORY AUTHORITY: National Centre for Medicines, Medical Devices, and Medical Equipment Expertise
CLASSIFICATION SYSTEM: Medical Devices and IVDs: Classes 1, 2a, 2b and 3.
TIMEFRAME: New Registration: 3-4 months
On-Site Audit: The manufacturing site inspection is required only for the registration of sterile class 2a, 2b, and 3 medical devices whose manufacturer has never been registered before in Kazakhstan or devices that require special maintenance and installation such as MRI and X-Ray machines. Class 1 and 2a non-sterile medical devices are exempted from this stage.
Local Tests/Permit: In-country local testing is required for all types of devices which include technical, biological, and measuring device testing.
Clinical Evaluation or Studies: Clinical studies are required for any type of medical device except Class 1 IVDs. The decision to conduct clinical studies is based on the recommendation of the expert organization.
LOCAL FEES (New Application)
According to Resolution No. 771/2015, the evaluation and/or registration fees vary depending on the authority (from a minimum of 48,000 KZT per unit until 577,000 KZT for complex capital equipment). This is determined right upon the medical device’s online submission.
LOCAL FEES (Manufacturer)
No manufacturer registration fee is required.
5 years (medical devices)*
7 years (medical equipment)*
*The current certificate is having 5 years validity, but it will become indefinite after the first renewal. The products that are submitted after January 27, 2021, however, will automatically have an indefinite registration certificate.
LICENSE TRANSFER: Transferring the license to a new authorized representative is possible and considered as making changes to the current registration certificate.
AUTHORIZED REPRESENTATIVE: Foreign manufacturer should appoint a legal entity located in Kazakhstan through legalized Power of Attorney to represent their interest and monitor the safety, quality, and effectiveness of medical devices in Kazakhstan.
ADDITIONAL INFORMATION: Most documents submitted should be translated into Russian; the IFU should be translated into both Russian and Kazakh
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* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.