For your products to legally enter the Ukrainian Market and continue to circulate, you must have valid documentation.

In accordance with Ukrainian legislation, all non-UA based medical device manufacturers shall have Authorized Representative (AR) in Ukraine.

Methodical recommendations are developed based on EU Guideline for Authorised Representatives – MEDDEV 2.5/10.

The Authorized Representative is a link between the non-UA manufacturer and the local market surveillance authorities (conformity assessment bodies, Ministry of Health, etc). 

Authorized Representatives shall bear the following responsibilities: supervise the compliance of the products on the market in accordance with the applicable procedures, maintenance and storage of technical documentation, participate in customer-feedback process and post-market surveillance activities.

Your relations with the Authorized Representative should be legally documented, fully indicating the power and responsibilities of both parties.

Designation of the proper Authorized Representative for your company is an important step forward for the successful market operations of your medical devices on the Ukrainian market.

Why? 

Because  the Authorized Representative knows local legislation. AR’s level of proficiency helps to speed up the necessary authorization procedures.

They can help avoid economic risks thanks to their knowledge and experience working with various Conformity Assessment Bodies. 

Your Authorized Representative is responsible for keeping your technical documentation up-to-date and secured.

Still have questions? Don’t hesitate and contact us! We will help.