The requirements of the Ukrainian market of medical devices have changed since July 2015. The state registration of a medical device was revoked, and manufacturers are now required to undergo the conformity assessment procedure following the Technical Regulations.
Accordingly, in order for a manufacturer to place a medical device on the Ukrainian market, the product must comply with the requirements covered under the Technical Regulations. In the case of complete compliance with the regulations, the certificate of conformity is obtained, and the national conformity mark is applied to the medical device packaging.
If you are a foreign manufacturer of medical devices and you are willing to supply your products to Ukraine, there is a need for an Authorized Representative in Ukraine. JERELO is qualified to offer you the service of the Authorized Representative.
The Authorized Representative is considered as the link between the competent authorities and the non-Ukrainian manufacturers. Every medical device that is supplied to Ukraine from non-Ukrainian manufacturers must display the information regarding the corresponding Authorized Representative, allowing the AR to be the primary contact for the Ukrainian authorities and consumers.
The JERELO team offers consultation on conformity assessment to provide further guidance for the required technical documentation and arrange the procedures promptly.
Feel free to contact us at any time for additional information!