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
REGULATORY AUTHORITY:
State Service of Ukraine on Medicines and Drug Control (SMDC)
CLASSIFICATION SYSTEM:
Medical Devices: I/IIa/IIb/III
IVDs: Self-declaration/List A/List B
TIMEFRAME:
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
SPECIAL REQUIREMENT:
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.
LICENSE VALIDITY:
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:
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.
AUTHORIZED REPRESENTATIVE:
The foreign manufacturer must appoint an Authorized Representative (AR) with a registered office in Ukraine.
ADDITIONAL INFORMATION:
•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) Countries: Belarus, Bosnia & Herzegovina, Iceland, Liechtenstein, Macedonia, Moldova, Norway, Serbia, Switzerland, Turkey
Last Update: September 2022
For detailed device-specific compliance information for each market, including Ukraine, to expedite the preparation of your medical device or IVD registration application.
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