Since 2017, Cratia has implemented and certified a quality management system under ISO 9001. To further enhance integration with medical device manufacturers’ systems, this year we have initiated the certification process according to the international quality standard ISO 13485, which is industry-specific for companies working with medical devices. We are delighted to announce that our […]

We invite you to the event, which will be useful for anyone interested in legalization and entering the Ukrainian and EU markets with cosmetic and medical products. At the seminar, you will receive comprehensive information on legal regulation and legalization procedures, as well as familiarize yourself with the specifics of entering the EU market. The […]

On December 12, 2023, Cratia conducted an educational webinar dedicated to the role, duties, and responsibilities assigned to an authorized representative (AR) in Ukraine. Maksym Bagrieiev, managing partner of Cratia, provided clear and transparent instructions that are highly valuable for both the AR and foreign manufacturers of medical products relying on the qualifications and reputation […]

On December 1, 2023, Cratia together with the Association of market operators of medical devices (AMOMD®) organized the first educational webinar on the regulation of assistive devices for rehabilitation and 3D printing of medical devices in Ukraine. This webinar became a significant event in technical regulation for the medical field, focusing on providing assistive devices […]

Following recent events, we conducted two webinars on November 21st and 24th, 2023, aimed at elucidating the procedures and benefits of recognition of CE certificates for medical devices in Ukraine. The first speaker was Viktoriia Moroz, a Key Account Manager, who discussed legislative requirements, the extension of the transitional period until December 31, 2028, and […]

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 […]