Kazakhstan Market Access for Medical Device

REGULATORY AGENCIES

• 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 Republic of Kazakhstan

REGULATIONS

• 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.

GUIDELINES

• 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.

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