News

Two webinars on the conformity assessment of medical products in Ukraine took place on November 7th and 14th, 2023, gathering experts from around the world and addressing key regulatory issues concerning medical devices in Ukraine. The first webinar, held on November 7th, focused on the fundamentals of compliance assessment and provided valuable information for importers, […]

We share updates regarding the regulation of medical devices in Ukraine: Suspension of accreditation of certification body “UMCS”; Cancellation of sanitary conclusions for medical devices as of October 1, 2023; Certain disinfectants are now classified as medical devices; New Technical regulations for aerosol sprayers; Metrological verification of medical devices. Suspension of accreditation and designation of […]

This article is informative and reflects our expert opinion and interpretation of the legislation. For official explanations, it is necessary to contact central executive bodies, in particular, the Ministry of Economic Development and the Ministry of Health. The measuring function is an integral part of many medical devices: analyzers, thermometers, tonometers, pulse oximeters, defibrillators, electrocardiographs, […]

Cratia participated in the “Dietary Supplements: Development Strategy” conference on October 12, 2023. Oksana Oliynichuk, the head of the FMCG department, discussed legislation and the main requirements for labeling dietary supplements, changes in legislation that will come into effect soon, the importance of correct labeling, and the responsibility associated with improperly labeled products. As Oksana […]

Cratia participated in the 32nd International Medical Exhibition “PUBLIC HEALTH 2023” as a leading professional consultant on medical products regulation. Viktoriia Moroz, Key Account Manager at Cratia, together with Mykola Matlaev, Lead auditor of the Conformity Assessment Department at Uni-Cert, conducted a 2-hour seminar on the topic “Introduction of medical devices for legal circulation”, attended […]

Cratia participated in the XVIII Specialized Conference “Beauty Tech. Innovations in Manufacturing: Raw Materials and Technologies.” Oksana Oliynyichuk, the head of the FMCG department, spoke about a new document that establishes requirements for cosmetics and the changes it will bring, as well as the practical steps that manufacturers and importers need to take to prepare […]

Cratia took part in the XVIII Specialized Conference “Beauty Tech. Innovations in Manufacturing: Raw Materials and Technologies.” Maksym Bagrieiev, managing partner of Cratia, shared his knowledge and advice on launching cosmetic products in the European market. Maxim noted that the technical regulation of cosmetic products in Europe is based on the principle of the “single […]

Cratia participated in the 12th Ukrainian Forum of Medical Device Market Operators, acting as an event sponsor and sharing important and current information about assessing the conformity of medical devices in Ukraine. The topic of the presentation was “Extension of recognition of MDD CE certificates until the end of 2028. Recognition of MDR and IVDR […]

We inform you of regulatory updates for medical devices in Ukraine: end of COVID quarantine results in cancelation of emergency authorizations and tax for certain medical devices; end of the transition period to e-Register for class I and in-vitro medical devices; extension of UA certificates issued through the recognition route till the end of 2027/28; […]