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 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.



ARE YOU INTERESTED IN REGISTRATION 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
latest news
  • Feb 21 2018
    REGULATORY UPDATE - TECRES MEDICAL

    Saudi Arabia: Tecres Medical's Rally Bone Cements were approved for sale with LICENSALE.COM®. ...

    Read More
  • Feb 19 2018
    REGULATORY UPDATE - LUMINEX

    Brazil: Luminex's xTAG Cystic Fibrosis 71 Kit v2 was approved for sale with LICENSALE.COM®. ...

    Read More
  • Feb 1 2018
    REGULATORY UPDATE - LEXMARK

    UAE: Lexmark's Media Writer, PACS Scan and EHR Gateway were approved for sale with LICENSALE.COM®. ...

    Read More
  • Jan 30 2018
    REGULATORY UPDATE - SYNTHETIC MR

    USA: Synthetic MR's SyMRI Neuro was approved for sale with LICENSALE.COM®. ...

    Read More
  • Jan 9 2018
    REGULATORY UPDATE - NOVASIGHT

    EU: Novasight's Eyeswift was approved for sale with LICENSALE.COM®. ...

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP