Medical Device Regulatory Requirements in Ukraine
| Regulatory Authority |
State Service of Ukraine
on Medicines and Drugs Control |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Resolution of the Cabinet of Ministers of Ukraine
| Click Here
|
| Registration Process |
State register of medical equipment and medical devices
| Click Here
|
| Registration Timeline |
3 months |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Ukrainian Language |
| Additional Information |
Medical Devices can only be sold in the market for up to five years from the date of issuance, without undergoing an evaluation method for compliance and marking by a national mark of conformity, before their expiration date. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025