Ukraine Medical Device Regulations

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Ukraine - Medical Equipment - International Trade …

https://www.trade.gov/country-commercial-guides/ukraine-medical-equipment

Jan 11, 2023 · Last published date: 2023-01-11. As a result of Russia’s full-scale invasion, Ukraine is facing persistent and intensifying public health challenges. In November 2022, the Minister of Health of Ukraine reported that Russian shelling had damaged 956 medical …

Changes in the medical device regulation in Ukraine - UNI …

https://uni-cert.ua/en/2022/08/12/zmini-u-regulyuvanni-medichnih-virobiv-v-ukraїni/

Aug 12, 2022 · Medical devices, active implantable medical devices and medical devices for in vitro diagnostics that have been placed on the market based on the Letter No. 24 …

Conformity assessment - УСА

https://uca.ua/en/conformity-assessment/

Feb 10, 2013 · From 1 July 2015, assessment of compliance with the requirements of technical regulations approved by Decrees of the Cabinet of Ministers No. 753, No. 754, …

Ukraine Medical Device Registration and Approval

https://arazygroup.com/medical-device-registration-ukraine/

Jan 9, 2023 · LOCAL FEES (New Application): Medical Device/IVDs – all classes. Full conformity assessment procedure: USD 5000 to 12500 (very depending on notified body) …

Ministry of Health of Ukraine introduces GMDN …

https://en.moz.gov.ua/article/news/ministry-of-health-of-ukraine-introduces-gmdn-classification-for-medical-devices

Jun 26, 2018 · The Ministry of Health of Ukraine plans to integrate the GMDN classification into the ProZorro public e-procurement system. This will allow optimizing the procurement …

Сертификация, регистрация медицинских изделий в …

https://cratia.ua/en/conformity-assessment-medical-devices

Under the “medical device” we mean medical devices, medical devices for in-vitro diagnostics and active implantable medical devices. Requirements for placing of medical …

Medical Device Registration and Supply in Ukraine

https://arazygroup.com/medical-device-registration-and-supply-in-ukraine/

Mar 11, 2022 · By Fajar Dumadi | March 11, 2022. In regards to the enforcement of martial law on February 24th, 2022, the Ministry of Health allows the supply of medical devices, …

Legislation - umcs.org.ua

https://www.umcs.org.ua/en/documents/legislation

Feb 15, 2023 · The Law of Ukraine “On Technical Regulations and Conformity Assessment” “The Technical Regulation for Medical Devices” approved by the decision of the Cabi...

Ukraine - Regulation for medical devices - BEAWIRE

https://beawire.com/cis/medical-device-registration-ukraine/

At July 01, 2015 marketing authorization requirements for medical devices have changed: system of state registration has been replaced by national conformity assessment to …