Medical Device Registration and Supply in Ukraine

By Fajar Dumadi | March 11, 2022

In regards to the enforcement of martial law on February 24th, 2022, the Ministry of Health allows the supply of medical devices, in-vitro diagnostics, and implantable medical devices that do not comply with the requirements of the relevant technical regulations. Therefore, the manufacturer can supply the devices without registration or certification. Currently there is no comprehensive list (any donations are welcome). However, these are some of the critical ones:

• Wound dressing
• Blood stoppers
• Surgical instruments
• Sterile surgical suits

In addition, the conformity assessment of medical devices is postponed until further notice. Some designated certification bodies are switching to remote work and are still maintaining critical business processes such as annual surveillance and re-certification.