REGULATORY AUTHORITY: 

Medical devices are regulated by the State Department of Medicine Provision and Medical Equipment, under the Kyrgyz Republic Ministry of Health.

CLASSIFICATION SYSTEM:

Kyrgyzstan follows the EU model of risk-based classification into Classes I, IIa, IIb and III.

TIMEFRAME:

The approval process takes between one and six months, depending on the documentation and class of the device.

LICENSE VALIDITY:

Licenses are valid for five years.

AUTHORIZED REPRESENTATIVE:

An authorized representative is required.

ADDITIONAL INFORMATION:

In August 2022, the Eurasian Commission proposed extending the transition period to switch from the national regulatory frameworks to the Eurasian Union regulation enforcement. The implementation of the EAEU unified procedure is extended to January 2026. Kyrgyzstan officially signed the protocol and is, therefore, accepting the submission under the national procedure until December 31st, 2025.

Other Central & East Asia Countries: Afghanistan,India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Sri Lanka, Taiwan, Tajikistan, Uzbekistan