Kazakhstan
Kazakhstan is the largest healthcare market in Central Asia, with growing demand for medical devices driven by government investments in the healthcare sector.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Ministry of Healthcare of the Republic of Kazakhstan, and the registration process is harmonized with the Eurasian Economic Union (EAEU).
Device Classification:
- Class 1: Low risk
- Class 2a, 2b: Moderate risk
- Class 3: High risk
Specific Local Requirements
| Language | Documentation in Russian and Kazakh. |
| Local Representative | Mandatory for foreign manufacturers. |
| EAEU Certification | Increasingly required in view of integration with the Eurasian Economic Union. |
Challenges and Operational Advice
- Variable timelines: The process can take over 24 months.
- Local audits: Possible inspections of manufacturing facilities.
Why Choose ISEMED
- EAEU Expertise
Qualified support in complying with Eurasian standards. - Comprehensive Assistance
From documentation preparation to liaising with the Ministry.
FAQ
- Is a local representative required? Yes.
- Documentation language? Kazakh and/or Russian.
- License duration? 5 years for certificates obtained under local legislation, unlimited for EAEU certificates.