Authorized Representative in Ukraine

On December 12, 2023, Cratia conducted an educational webinar dedicated to the role, duties, and responsibilities assigned to an authorized representative (AR) in Ukraine.

Maksym Bagrieiev, managing partner of Cratia, provided clear and transparent instructions that are highly valuable for both the AR and foreign manufacturers of medical products relying on the qualifications and reputation of a specific AR in Ukraine.

According to Ukrainian legislation, a non-resident manufacturer must designate an AR in Ukraine. The manufacturer can designate only one AR for a specific type/model of medical device.

It is considered that the AR should be the regulatory representative in Ukraine, since the AR ensures proper conformity assessment for medical devices, fully interacts with the competent authorities, representing the manufacturer. Based on the definition provided in the Law “On General Safety of Non-Food Products”, the manufacturer is represented in Ukraine through its AR.

The AR must carry out a series of tasks on behalf of the manufacturer, as well as fulfill its role, duties, and obligations according to Ukrainian legislation. Specifically, the AR is obliged to:

• maintain documentation on medical products and the manufacturer’s QMS (Quality Management System), which competent authorities can ask;
• provide a declaration of conformity to the requirements of all applied technical regulations to market surveillance authorities;
• provide technical documentation upon request from market surveillance authorities and cooperate with them;
• provide market surveillance authorities with all necessary information to confirm the conformity of medical products with all applicable requirements;
• inform the manufacturer about any actions related to the placing on the market or putting into service of medical products;
• notify the manufacturer of decisions by the competent authority regarding refusal, restriction, or prohibition of medical products’ market access;
• inform the manufacturer of known adverse events, incidents, complaints, etc.;
• report to competent authorities within 2 working days about medical devices not meeting the requirements of technical regulations and safety requirements in the form of notification established by Ukrainian legislation;
• collaborate with authorities to take measures to mitigate risks caused by medical devices;
• support and assist the manufacturer in taking actions to ensure the safety of medical devices;
• provide transport documentation upon request from market surveillance authorities, allowing the identification of medical devices in the supply chain, and so forth.

The AR bears primary responsibility for medical devices and, notably, pays fines instead of the manufacturer.

Trade representatives of the manufacturer (e.g., distributors or agents) should not be confused with the AR. While the AR can also act as an importer or distributor, in such cases, they are obliged to fulfill duties as both an importer / distributor and as the AR. Often, designating the AR role to one of the manufacturer’s trade representatives effectively limits the manufacturer in marketing and sales strategies.

Thus, the AR acts as the intermediary with authorities instead of the manufacturer. The AR should assess the manufacturer’s capability to fulfill regulatory obligations and verify the existence of necessary information / documentation within the manufacturer and its post-market surveillance, vigilance, and other obligations. Therefore, the AR must possess appropriate regulatory knowledge, skills, resources, and qualified personnel to conduct such assessments, checks, and, of course, fulfill their role and assigned duties. If necessary, the AR may engage a regulatory consultant to perform certain functions, effectively outsourcing them.

This webinar was conducted in English, providing a unique opportunity for foreign manufacturers to obtain key information regarding the duties of the AR in Ukraine and to increase awareness of Ukrainian legislation.

If you have any questions, please feel free to contact us. We will be happy to assist in finding the right solution for any situation.

Our company is a leading professional regulatory consultant in Ukraine. “Cratia Medtekhnika” LLC has extensive experience as an AR and enjoys high trust from several hundred foreign manufacturers.

You can send inquiries to our email: info@cratia.ua. Additionally, you can reach us by phone at: +38 (068) 064-78-31, where you will receive immediate consultation regarding medical devices.

Best regards,
The Cratia Team