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.

We review our Regulatory Information frequently; please check back often for updates

Medical Device Regulations and Classification in Ukraine


State Service of Ukraine on Medicines and Drug Control (SMDC)



Medical Devices: I/IIa/IIb/III

IVDs: Self-declaration/List A/List B



Medical Device/IVDs – all classes

Full conformity assessment procedure: 2-3 months

Batch verification procedure: 2-3 weeks

EC certificate recognition procedure: 1-2 months



Factory inspection will be required for devices registered using Full Conformity Assessment procedure.

Local testing is mandatorily required for devices registered under the Batch Verification procedure.

Local clinical study is not required.


LOCAL FEES (New Application):

Medical Device/IVDs – all classes

Full conformity assessment procedure: USD 5000 to 12500 (very depending on notified body)

Batch verification procedure: USD 2000 to 2500 (very depending on notified body)

EC certificate recognition procedure: USD 3500 to 5000 (very depending on notified body)


LOCAL FEES (Manufacturer):

Not applicable.



Full conformity assessment procedure: maximum 5 years.

Batch verification procedure: follow the expiry date of the exact batch/shipment.

EC certificate recognition procedure: follow the expiration date of recognized CE Certificate.



License transfer from the current to the new authorized representative (AR) is possible. The manufacturer should terminate the current AR and start the process from the beginning with the new AR.



The foreign manufacturer must appoint an Authorized Representative (AR) with a registered office in Ukraine.



•The manufacturers now have an option to use electronic IFU (e-IFU). This option, however, only available for certain type of devices and a risk assessment must be provided to justify the option. In addition, the manufacturer must notify their notified body before implementing this option.

•As of July 2022, Ukrainian conformity assessment bodies have recognition Agreements with more than 30 notified bodies from the EU.

Other Europe (non-EU) CountriesBelarusBosnia & HerzegovinaIcelandLiechtensteinMacedoniaMoldovaNorwaySerbiaSwitzerlandTurkey

Last Update: September 2022

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