1. To get a medical device approved in Ukraine, manufacturers must appoint an authorized representative in Ukraine who can be a distributor or representative office. The manufacturer then identifies the appropriate technical regulations for the device and chooses a conformity assessment procedure. 2. The manufacturer prepares a technical file demonstrating compliance with the requirements in the chosen regulations. They then select a Notified Body to review the file and certify compliance with quality standards. 3. Upon approval, the authorized representative's name and address and the Ukrainian conformity assessment mark must be placed on the device labels and packaging.