Authorized Representative for foreign (non-Ukrainian) medical device manufacturers

According to the current Ukrainian legislation, all non-resident medical device manufacturers that supply their products to Ukraine are required to possess an Authorized Representative (AR) in this country.

The Authorized Representative is regarded as the link between the non-resident manufacturer and the local market surveillance authorities. The responsibilities of an AR include the following: monitoring of the compliance of the products that are launched on the Ukrainian market with the adopted procedures, maintenance and storage of technical documentation, feedback management and control (feedback received from manufacturer, consumers, and market surveillance authorities).

Choosing the proper Authorized Representative for your company is a huge step forward for the successful merchandise of your products on the Ukrainian market.

Firstly, it is the knowledge of local legislation and the level of proficiency of the Authorized Representative that determine the speed of necessary authorization procedures.

Secondly, the understanding and appraisal of the strengths and weaknesses of various Conformity Assessment Bodies can be beneficial for the arrangement of the conformity assessment procedures as well as for the avoidance of economic risks.

Thirdly, the Authorized Representative is the one that keeps every piece of technical information regarding your company; Therefore, the confidentiality of your documentation is utterly dependent upon the proper implementation of the latter-day means of data protection.

Moreover, the relationship between the Manufacturer and the Authorized Representative shall be legally documented, fully indicating the power and responsibilities of both parties.

If you require any further information or assistance regarding the Authorized Representative matter, do not hesitate to contact us!