Ministry of Health

Ministry of Healthcare of the Republic of Kazakhstan

Regulatory Authority

National Centre for Medicines, Medical Devices and Medical Equipment Expertise

Medical Device Regulation

• ҚР DSM-10 “On approval of the rules for the examination of medicines and medical devices” – Article 239
• On approval of the rules for state registration, re-registration of a medicinal product or medical device, amendments to the registration dossier of a medicinal product or medical device

Official Language

Kazakh and Russian

Classification

Class I, IIa, IIb and III

Process of Medical Device Registration in Kazakhstan

• To register a device it is necessary to submit the registration documents in electronic format, translated into Russian, at the National Center for the Expertise of Drugs and Medical Devices which will review the documentation.
• The latter will carry out a detailed examination through a primary, analytical analysis (only for some devices) and a special analysis of the documentation and sample of the device submitted.
• An inspection is planned by the Regulatory Authority to the manufacturer in case of device first placing on the market and devices requiring special installation and maintenance conditions.
• In case of a successful outcome, a registration certificate will be issued. Registered medical devices are posted on the National Center for Expertise of Drugs and Medical Devices web page.

Documents Required

• Agreement
• Contract for assessment of production conditions and quality assurance system
• Application form
• List of documents in the registration dossier
• List of documents for amendment (if any)
• The electronic format of the registration dossier
• IFU or User manual
• Acceptance and Transfer letters for registration dossier

Applicable QMS

GMP or ISO 13485

Registration Timeline

4 – 10 months

Authorized Representative

Yes

License Validity

• Medical device – 5 years
• Medical Equipment – 7 years