Medical equipment, devices and products may be only sold and used for the purpose of medical practice in Ukraine upon their public registration in a due and defined manner.
The public registration procedure includes series of expert examinations (expertise) and trials as to the quality, safety and efficacy of items and products in question, and takes up to ninety (90) days.
Between applying to the Ministry of Health of Ukraine and receipt the Registration Certificate, an applicant will cooperate with experts and appear before entities and organizations performing trials and expert examination (expertise).
The public registration procedure for foreign manufactures substantially differs from that for domestic manufacturers, that’s why an applicant shall have an extensive knowledge of medical devices manufacturing, application and operation peculiarities, and basic legal norms, acts and regulations applicable in Ukraine and in the relevant country of origin.
We will readily assist you to register medical equipment, devices and products in Ukraine.
