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China is one of the world’s largest producers of medical devices. Yet for many Chinese manufacturers, the Ukrainian market remains largely unexplored — not...

During wartime, any market is instinctively perceived as either “frozen” or merely surviving in a formal sense. The Ukrainian medical device market is no...

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...

Over the past two weeks, several manufacturers contacted us regarding the change of their Authorised Representative (AR) in Ukraine. In most cases, the reason...

1. Multi-level regulation By definition, a medical device must comply with the technical regulations in the field of medical devices (in Ukraine: TRs No....

In 2025, Ukraine is actively preparing for a major reform of its regulatory framework for medical devices. The main objective is to align national...

All medical devices intended for placing on the Ukrainian or EU market must undergo clinical evaluation. This does not always mean conducting a clinical...

Introduction: War Doesn’t Stop the Market Despite full-scale war and ongoing economic challenges, Ukraine’s medical device market remains resilient and active. In 2025, procurement,...

In 2024, Ukraine made further progress in digitalizing regulatory procedures for medical devices. The Ministry of Health and the State Service of Ukraine on...