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Clinical Evaluation of Medical Devices in Ukraine: Are Clinical Trials Really Necessary?

26.06.2025

Clinical Evaluation of Medical Devices in Ukraine: Are Clinical Trials Really Necessary?

All medical devices intended for placing on the market in Ukraine or the EU must undergo clinical evaluation. This does not necessarily mean conducting...

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Medical Device Market in Wartime Ukraine: Risks, Dynamics, Opportunities

14.06.2025

Medical Device Market in Wartime Ukraine: Risks, Dynamics, Opportunities

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,...

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Digitalization in Medical Device Regulation: Ukraine Expands e-Services for Importers

05.07.2024

Digitalization in Medical Device Regulation: Ukraine Expands e-Services for Importers

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

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Focus on Infection Control: Ukraine Increases Demand for Sterilization and Disposable Products

12.09.2023

Focus on Infection Control: Ukraine Increases Demand for Sterilization and Disposable Products

In 2023, Ukrainian healthcare institutions increased their focus on infection prevention and control. This trend was reflected in the rising demand for disposable instruments,...

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Procurement of Medical Devices in Ukraine: Trends of 2022

15.03.2022

Procurement of Medical Devices in Ukraine: Trends of 2022

Despite growing geopolitical instability in early 2022, public procurement of medical devices in Ukraine remained active. Through the Prozorro system, hospitals and clinics continued...

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Labeling Requirements for Medical Devices: Overview of the 2021 Updates

14.06.2021

Labeling Requirements for Medical Devices: Overview of the 2021 Updates

In 2021, Ukraine updated its approach to medical device labeling in line with current Technical Regulations. The Ministry of Health emphasized the need to...

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Competition in the Ukrainian medical device market will increase

13.03.2019

Competition in the Ukrainian medical device market will increase

The government abolished the 10% marginal surcharge. This decision will allow to expand the range of foreign medical devices – convinced operators of medical...

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The Ministry of Health of Ukraine will introduce the GMDN-classifier of medical devices

26.06.2018

The Ministry of Health of Ukraine will introduce the GMDN-classifier of medical devices

GMDN is an international classifier used to clearly identify materials, tools, implants and medical equipment. It enables doctors and purchasers to know the exact...

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