Kazakhstan
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application. 

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 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.



Interested in obtaining fast market approval for your medical device or IVD in Kazakhstan? REQUEST A FREE QUOTE>

For more information on registration in Kazakhstan, check out the following articles on our blog:
Country at a Glance: Kazakhstan
Case Study: The Rewards of Expert Regulatory Navigation in Kazakhstan
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