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Can a Foreign Manufacturer Sell Medical Devices in Ukraine Directly? Tender Rules, Delivery Terms and a One-Month Market Snapshot

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...

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What Does Medical Device Registration in Ukraine Actually Cost? A Cost-Structure Guide for Manufacturers

30.09.2026

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,...

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Ukraine Adopts EU MDR-Aligned Medical Device Regulations: What Manufacturers Should Do Before 2030

21.07.2026

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...

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How Much Does an AI-Written Clinical Evaluation Report Actually Cost?

26.06.2026

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...

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Why Used CE-Marked Medical Equipment Can’t Simply Be Imported into Ukraine

15.05.2026

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:...

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How Chinese Medical Device Manufacturers Can Enter the Ukrainian Market: A Practical Guide

12.04.2026

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...

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Ukrainian Medical Device Market During the War: A Patient More Alive Than Dead

20.01.2026

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...

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Post-Market Surveillance Under EU MDR: Understanding PMS, PMCF and PSUR

24.11.2025

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...

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Changing the Authorised Representative in Ukraine: What Manufacturers Should Know

31.10.2025

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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