News

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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08.06.2022

UNI-CERT received accreditation for DSTU EN ISO 22716:2015

The Ukrainian Scientific Institute of Certification became the FIRST conformity assessment body in Ukraine, accredited to carry out activities in a new line of business: DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practices (EN ISO 22716:2007, IDT) and EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines […]

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30.05.2022

The Pharmacy weekly has published a review article about the seminar “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”

On May 19, a webinar was held on the topic: “Relevance of medical device conformity assessment through EC-certificates recognition during martial law”, the speakers of which were Viktoriia Shevchenko, Head of the Conformity Assessment Department of UNI-CERT LLC and Yana Sydiakina, Leading Specialist of the Assessment Division of UNI-CERT LLC. The seminar showed the great […]

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05.05.2022

Free laboratory tests to support the Armed Forces of Ukraine and humanitarian aid!

Dear volunteers, friends, colleagues! The Ukrainian Scientific Institute of Certification has its own accredited testing laboratory, which provides laboratory testing for compliance with the requirements of 49 international and domestic standards for 146 test methods for medical devices and personal protective equipment. If you or your partners need to conduct laboratory tests of products supplied […]

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15.04.2022

Conformity assessment requirements for subcontracting manufacture (OBL-OEM). Technical file structure.

The program of the event is available only on Ukrainian or Russian

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