News
25.10.2026
Can a Foreign Manufacturer Sell Medical Devices in Ukraine Directly? Tender Rules, Delivery Terms and a One-Month Market Snapshot
Foreign manufacturers often ask us whether they can take part in Ukrainian public tenders without a local distributor. We analysed medical equipment and supplies...
More details30.09.2026
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 details21.07.2026
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 details26.06.2026
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 details15.05.2026
Why Used CE-Marked Medical Equipment Can’t Simply Be Imported into Ukraine
A practical guide for importers, clinics and distributors A typical situation Importers and clinic owners regularly come to me with roughly the same request:...
More details12.04.2026
How Chinese Medical Device Manufacturers Can Enter the Ukrainian Market: A Practical Guide
China is one of the world’s largest producers of medical devices. Yet for many Chinese manufacturers, the Ukrainian market remains largely unexplored — not...
More details20.01.2026
Ukrainian Medical Device Market During the War: A Patient More Alive Than Dead
During wartime, any market is instinctively perceived as either “frozen” or merely surviving in a formal sense. The Ukrainian medical device market is no...
More details24.11.2025
Post-Market Surveillance Under EU MDR: Understanding PMS, PMCF and PSUR
Under the EU Medical Device Regulation (EU MDR 2017/745), every manufacturer placing a medical device on the EU market must implement a comprehensive post-market...
More details31.10.2025
Changing the Authorised Representative in Ukraine: What Manufacturers Should Know
Over the past two weeks, several manufacturers contacted us regarding the change of their Authorised Representative (AR) in Ukraine. In most cases, the reason...
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