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: Medical devices are regulated by the Ministry of Health (MOH).

CLASSIFICATION SYSTEM: Medical devices are classified according to EU risk-based model into Classes I, IIa, IIb, III, and IV.

TIMEFRAME: The medical device registration process ranges from four months for Class I devices to ten months for Class III devices.

LICENSE VALIDITY: Licenses issued in Kazakhstan are valid for five years.

AUTHORIZED REPRESENTATIVE: A local authorized representative is required.

ADDITIONAL INFORMATION: Most documents submitted should be translated into Russian; the IFU should be translated into both Russian and Kazakh.

Last updated on January 9 2018.

 

Other Central & East Asia Countries:

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

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