Kyrgyzstan
Kyrgyzstan is an emerging market in Central Asia, characterized by a strong dependence on imported medical devices and government investments aimed at improving the healthcare system.
Do you require help or further information?
Contact us! We are happy to advise you:
Regulatory Framework
The competent authority is the Ministry of Health of the Kyrgyz Republic, and the country is part of 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 Kyrgyz and/or Russian. |
| Local Representative | Mandatory for foreign manufacturers. |
| EAEU Certification | Important to facilitate access to other member countries. |
Challenges and Operational Advice
- Variable timelines: The process can take over 24 months. The duration of the local procedure may vary significantly depending on the device type.
- Local audits: Potential inspection of manufacturing facilities.
- Local procedure: Additional requirements may be requested for complex devices.
Why Choose ISEMED
- EAEU Expertise
Specific support for accessing Eurasian markets. - Comprehensive Assistance
From dossier preparation to direct interaction with the Ministry.
FAQ
- Is a local representative required? Yes.
- Documentation language? Kyrgyz and/or Russian.
- License duration? 5 or 7 years for certificates under local legislation, unlimited for EAEU certificates.