If you are a foreign manufacturer planning to place medical devices on the Ukrainian market, you are required by law to appoint an Authorized Representative (AR) in Ukraine. RAA acts as your official Authorized Representative — handling all regulatory obligations on your
behalf, so you can focus on your business.
What is an Authorized Representative?
An Authorized Representative in Ukraine is a legal entity or individual entrepreneur registered in Ukraine, appointed by a foreign manufacturer to act on their behalf in
all regulatory matters related to medical devices.
The AR is mandatory for all foreign manufacturers under Technical Regulations No. 753, 754, and 755. Their name and address must appear on the device labeling and in the
Instructions for Use.
What RAA does as your AR
– Initiates and manages the conformity assessment procedure on your behalf
– Maintains your technical documentation for at least 5 years
– Communicates with the State Service of Ukraine on Medicines and Drugs Control
– Participates in market surveillance inspections
– Reports adverse events and incidents to authorities
– Keeps you informed about changes in Ukrainian medical device regulations
– Issues and manages the Declaration of Conformity
– Interacts with appointed distributors and importers: issues authorization letters for product import, supports documentation required for customs clearance and market access
Why choose RAA?
– 10+ years of experience in Ukrainian medical device regulation
– Fully independent from importers and distributors — no conflict of interest
– Currently representing manufacturers from the EU, Asia, and beyond
– Personal approach: you always communicate directly with the responsible expert
– Transparent pricing: annual fee from 1,400 to 1,800 EUR depending on scope
How it works
1. You contact us and describe your product and current documentation
2. We assess the scope of AR obligations for your specific device
3. We prepare and sign the Authorized Representative Agreement and Power of Attorney
4. We initiate the conformity assessment procedure
5. We maintain ongoing regulatory compliance on your behalf
Also looking for an EU market?
If you are a Ukrainian manufacturer planning to enter the European market, RAA can assist you in finding and selecting a suitable EU Authorised Representative — a
mandatory requirement under EU MDR/IVDR for manufacturers outside the EU.
Ready to appoint your Authorized Representative in Ukraine? Contact us at s.kharchenko@yahoo.com or complete the contact form below.
We will review your case and provide a clear proposal within 2 business days.