MEDICAL DEVICE REGISTRATION AND APPROVAL IN Kyrgyzstan

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 update: December 2022

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, IndiaJapanKazakhstanKyrgyzstanNepalRussiaSouth KoreaSri LankaTaiwanTajikistanUzbekistan

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