Authorized Representative in Ukraine

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Authorized Representative in Ukraine: Legal Definition

According to the requirements of Technical Regulations on medical devices No. 753, No. 754, and No. 755, a foreign manufacturer must appoint an Authorized Representative in Ukraine to place medical devices on the market in Ukraine. According to Technical Regulation No. 753:

“An Authorized Representative is any legal entity or individual entrepreneur who is a resident of Ukraine or registered according to Ukrainian legislation, representing a foreign business entity, and has duly confirmed authority from the manufacturer to perform legal actions on their behalf concerning the manufacturer’s obligations established by this Technical Regulation.”

Responsibilities of an Authorized Representative

Therefore, to market medical devices in Ukraine, foreign manufacturers need to appoint an Authorized Representative who is a resident of Ukraine. The responsibilities of the Authorized Representative typically include:

Preparation of documentation for medical devices for the Ukrainian market: declarations, instructions for use, labeling, and checklists for compliance with the Technical Regulations
Transmitting complaints from the Ukrainian market to the manufacturer after the medical device is introduced to the market
Informing the local competent authority (State Service of Ukraine for Medicines and Drug Control) about any incidents in the Ukrainian market
Storing the manufacturer’s technical documentation on medical devices

According to the Law of Ukraine “On State Market Surveillance and Control of Non-Food Products”, which covers medical devices to ensure product compliance with established requirements and to prevent threats to public interests, market surveillance is carried out by competent authorities according to plans set by these authorities.

Competent Authority: State Service of Ukraine on Medicines and Drugs Control

For medical devices, the competent authority is the State Service of Ukraine for Medicines and Drug Control (State Service of Ukraine for Medicines and Drug Control).

The company Med Quality can be your reliable partner and either act as your Authorized Representative or help you compile the complete documentation package to avoid any issues from consumers or the State Service during planned market surveillance activities.

Authorized Representative in Ukraine