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.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.