Events

01.02.2023

Register of persons responsible for the placing medical devices on the market has become operational in Ukraine

The Register of persons responsible for the placing medical devices on the market is displayed in public access on the official website of the State Service of Ukraine on Medicines and Drugs Control, providing the possibility of convenient search of information in the Register of Persons in accordance with the specified search parameters, at the […]

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09.01.2023

Public health: more time to certify medical devices to mitigate risks of shortages

On January 6, 2023 the European Commission adopted a proposal to give more time to certify medical devices to mitigate the risk of shortages. The proposal introduces a longer transition period to adapt to new rules, as foreseen under the Medical Devices Regulation. The new deadlines depend on the medical devices’ risk class and will […]

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29.08.2022

The 11th Ukrainian forum of medical device market operators was held

On August 26, the 11th anniversary Ukrainian forum of medical device market operators took place, which provided manufacturers, suppliers, distributors, importers of medical devices with a platform for communication and exchange of valuable business experience during martial law. Ukrainian Scientific Institute of Certification was traditionally a partner of this event. In addition, Victoria Shevchenko, Head […]

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22.08.2022

Features of medical device conformity assessment in wartime with or without conformity assessment body involvement

The Ukrainian Scientific Institute of Certification invites you to take part in the 11th Ukrainian Forum of Medical Devices Market Operators®. In this difficult period for our country, more than ever, it is necessary to be aware of the latest key changes in the functioning of the medical device market. Therefore, the Ukrainian Forum of […]

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12.08.2022

Changes in the medical device regulation in Ukraine

In connection with the establishment of conformity assessment processes and the possibility of carrying out works that ensure the availability of the necessary products on the Ukrainian market with confirmed safety and efficiency, on August 9, 2022, the Ministry of Health withdrew the letter dated February 25, 2022 No. 24-04/5396/2-22 allowing the placing of the […]

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27.07.2022

The entry into force of the Technical Regulations for cosmetic products has been postponed for 2 years

On July 26, 2022, the Cabinet of Ministers of Ukraine adopted a resolution “On Amendments to the Resolution of the Cabinet of Ministers of Ukraine dated January 20, 2021 No. 65” in order to postpone the date of entry into force of the Technical Regulations for cosmetic products and introduce a transitional period in this […]

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