MEDICAL DEVICE REGISTRATION AND APPROVAL IN Kazakhstan

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 update: November 2023

Medical Device Regulations and Classification in Kazakhstan

REGULATORY AUTHORITY: REGULATORY AUTHORITY:

National Centre for Medicines, Medical Devices, and Medical Equipment Expertise

CLASSIFICATION SYSTEM: Medical Devices and IVDs: 1/2a/2b/3

TIMEFRAME: New Registration: 2-3 months for Class 1 and Class 2a and 5 months for Class 2b and Class 3.

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.

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:

  • 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: In August 2022, the Eurasian Commission proposed an extension to the transition period to switch from the national regulatory frameworks to the Eurasian Union regulation enforcement:

The implementation of the EAEU unified procedure is extended to January 2026.

Up today, Kazakhstan has officially signed the protocol and, therefore, is accepting the submission under the national procedure until December 31st, 2025.

JUST SAY WHEN!

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