The act of registering or re-registering medical use products in Ukraine is performed by the State Department of Quality Control, Safety and Manufacture of Medicinal and Medical Use Products. Registration Procedures Procedures for registering medical equipment and medical use products were approved by the Ministry of Health of Ukraine on September 26, 2000. Registration is a requirement for the importation of medical products into Ukraine. Registration is performed by the State Department on Control of Quality, Safety and Manufacture of Medicinal and Medical Use Products, and is based on evaluation of the product by expert testing agencies. Once registered, a product is included in the State register of medical equipment and medical use products.
Registration is valid for five years.
The procedure for renewal of registration is the same as described above. Ukrainian customs code for the medical use product. B. A certificate of conformance issued by a Ukrainian certifying agency. I certify that the applying product complies with quality and safety requirements, as stated in the supporting documentation, and with requirements of Ukrainian legislation as to quality and safety for human health and the environment.