Regulatory Authority

State Administration of Ukraine on Medicinal Products (SAUMP)


I, IIa, IIb, III

Quality system

ISO 9001 and ISO 13485:2016

Medical Devices and IVDs are subject to registration.
Foreign manufacturers must appoint an Authorized Representative based in Ukraine.
As of July 2015, the new national compliance system came into force and providing several device registration procedures.


Local Authorized representative.

Labelling and documentation language

Documentation and labelling must be provided in Ukrainian.

Useful information

There are obligations imposed by the Ukrainian “Protection of Consumers’ Rights”.

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