The State Service of Ukraine on Medicines and Drugs Control informs on recognition of the results of the assessment of conformity of medical products
The State Service of Ukraine on Medicines and Dugs Control informs that during martial law the introduction into circulation and/or operation of medical devices/ systems of medical devices/treatment kits, medical devices for in vitro diagnostics, active implantable medical devices for which the requirements of the Technical Regulations for Medical Devices approved by the resolutions of the Cabinet of Ministers of Ukraine dated 02.10.2013 № № 753, 754, 755 respectively are not met, is permitted when the conformity assessment results of the conformity assessment carried out by foreign accredited conformity assessment bodies are recognized by the designated body in accordance with the requirements of Article 45, parts 1 and 3, of the Law of Ukraine On Technical Regulations and Conformity Assessment, in accordance with the resolution of the Cabinet of Ministers of Ukraine dated 29.03.2022 № 389 On amending some decisions of the Cabinet of Ministers of Ukraine on the recognition of the results of conformity assessment.