Сonsulting agency for conformity assessment, registration and certification of medical devices
Need registrationRAA is an independent medical device and IVD registration agency in Ukraine and an Authorized Representative for foreign manufacturers. 25+ years in regulatory affairs and over 100 registrations as RAA. Our clients include manufacturers from Europe, Asia and the USA. Every project is led by the founder personally.
More than 10 years
work experience
Over 100 projects
were implemented
Independent
Authorized Representative
Fair pricing
transparent quotes
Last news
30.9.2026
What Does Medical Device Registration in Ukraine Actually Cost? A Cost-Structure Guide for Manufacturers
The Ukrainian medical device market didn’t stop during the war. Demand shifted, it didn’t disappear: some purchasing moved into the Prozorro Market electronic catalog,...
More details
21.7.2026
Ukraine Adopts EU MDR-Aligned Medical Device Regulations: What Manufacturers Should Do Before 2030
On 10 June 2026, the Cabinet of Ministers of Ukraine approved two landmark resolutions — No. 758 and No. 759 — introducing new Technical Regulations for...
More details
26.6.2026
How Much Does an AI-Written Clinical Evaluation Report Actually Cost?
The EU and US markets remain the most attractive expansion targets for medical device manufacturers looking to grow beyond their home market: higher price...
More details