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.
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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