Medical Device Registration in
Ministry of Health
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
Kazakh and Russian
Class I, IIa, IIb and III
- 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.
- 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
GMP or ISO 13485
4 – 10 months
- Medical device – 5 years
- Medical Equipment – 7 years