Control committee of medical and pharmaceutical activity, Pharmaceutical Control Division of Alma-Ata under the Ministry of Healthcare and Social Development of the Republic of Kazakhstan
National Center for Expertise of Drugs and Medical Devices Ministry of Health Rebublic of Kazahstan
Order No 735 from 18 November 2009 "Registration, Reregistration, change notification rules of pharmacy product and medical devices".
Order No 736 from 18 November 2009 "Rules for expertise of pharmacy product and medical devices".
Approval of medical products in Kazakhstan is mandatory. The applicant should pay fees to the Pharmaceutical Control Division of Alma-Ata and submit technical file for review to the National Center for Expertise of Drugs and Medical Devices.
The review consists of documentation review, device testing, expertise and sometimes a manufacturer’s audit.
Upon successful review, a registration certificate is issued with 5 and 7 years validity respectively for medical devices and medical equipment.
The manufacturer should consider, if local representative or the manufacturer shall be the owner of the Registration Certificate.
Listing of the device components in a registration certificate should be confirmed with the local distributor/customs broker before the registration process starts.
Device risk classification is similar to that in Europe.
Registered medical devices are published on the webpage of National Center for Expertise of Drugs and Medical Devices.
Applicable product categories
To determine if a particular product is subject to the above regulation or can be registered under accelerated process (within only 5 working days), please contact us.