Medical Device Registration and Approval in Kyrgyzstan
General country-specific regulatory information is provided on this page for medical device registration and approval in Kyrgyzstan.
Last updated on November 22nd, 2021.
Medical Device Regulations and Classification in Kyrgyzstan
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.
Other Central & East Asia Countries: Afghanistan, India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Sri Lanka, Taiwan, Tajikistan, Uzbekistan
For detailed device-specific compliance information for each market, including Kyrgyzstan, to expedite the preparation of your medical device or IVD registration application.
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