Digitalization in Medical Device Regulation: Ukraine Expands e-Services for Importers

In 2024, Ukraine made further progress in digitalizing regulatory procedures for medical devices. The Ministry of Health and the State Service of Ukraine on Medicines and Drugs Control (SMDC) expanded their use of online tools, making processes more transparent and predictable for international suppliers.

Importers can now submit registration documents, declarations of conformity, and changes to product information through the electronic cabinet system. These updates significantly reduced administrative delays and improved communication between applicants and regulatory authorities.

Additionally, the use of QR codes on medical device labels — linking directly to IFU and certificates — became more widespread, aligning with EU trends in digital documentation.

This digital shift created new opportunities for EU and Chinese manufacturers to enter the Ukrainian market with streamlined logistics and lower compliance barriers.