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. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Kazakhstan, to expedite the preparation of your medical device or IVD registration application.

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

SPECIAL REQUIREMENTS:

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.

LICENSE VALIDITY: 

Medical Devices- 5 Years

Medical Equipment – 7 Years

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.

Last updated on October 29th, 2020

 

Other Central & East Asia Countries:

Afghanistan, China, IndiaJapan, Kyrgyzstan, Nepal, Russia, South Korea, Taiwan, Tajikistan, Uzbekistan

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