Regulatory Authority
State Administration of Ukraine on Medicinal Products (SAUMP)
Classification
I, IIa, IIb, III
Quality system
ISO 9001 and ISO 13485:2016
The information on this page is valid and current as of January 2017. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer
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.
Applicant
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”.
