Labeling Requirements for Medical Devices: Overview of the 2021 Updates

In 2021, Ukraine updated its approach to medical device labeling in line with current Technical Regulations. The Ministry of Health emphasized the need to provide information in Ukrainian and to follow the labeling structure outlined in Annex 1 of Technical Regulations No. 753, No. 754, and No. 755.

Special attention was given to product identification, instructions for use (IFU), and contact details of the authorized representative. For importers and distributors, compliance with these requirements became essential for customs clearance.

In practice, manufacturers from the EU and China had to adapt their labeling, translate IFUs, and update registration dossiers in accordance with Ukrainian legislation.