: 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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