Medical Device Registration and Approval in Ukraine

General country-specific regulatory information is provided on this page for medical device registration and approval in Ukraine. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Ukraine, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Ukraine

REGULATORY AUTHORITY: Medical devices must be approved by the State Inspectorate for Quality Control under the Ministry of Health (MOH). Registration with the Ukrainian MOH, obtaining a National Mark of Conformity and listing in the State Registrar of Medical Equipment and Products are all required for a device to be sold.

CLASSIFICATION SYSTEM: Medical devices in Ukraine are divided into four classes (I, IIa, IIb and III) based on risk level.

TIMEFRAME: The registration process takes 5-6 months of working days after submission.

LICENSE VALIDITY: Licenses issued in Ukraine expire after five years.

AUTHORIZED REPRESENTATIVE: A local representative is required.

Last updated on March 17 2015.

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