News

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 draw your attention to the changes in the regulation of medicines regarding: publication of the Risk Management Plan (RMP) summary on the State Expert Center website for public access, technical features regarding indication of prefixes (serial number, expiration date) in the packaging graphic layouts and logos in the labeling texts. Both procedures are caused […]

As of the beginning of 2023, according to official data, at least 1,200 healthcare institutions in Ukraine have been damaged, and about 200 of them have been completely destroyed. It is not just the medical infrastructure that has been affected, the war causes high civilian casualties every day and forces people to move within and […]

We share news on the regulations concerning cosmetic products, disinfectants, and dietary supplements in Ukraine. Cosmetic products and disinfectants (biocides): We want to bring your attention to a situation that may occur in the regulatory field in about 3.5 months. After October 1, 2023 it might become impossible to obtain the necessary permits for introducing […]

We highlight important regulatory news regarding medical devices in Ukraine in late 2022 and early 2023. 1. Electronic register of class I medical devices and devices for in-vitro diagnostics  Register of class I medical devices and IVDs has been transferred into electronic format following changes to Order 122 of the Ministry of Health of Ukraine […]

We provide a rundown of the most critical regulatory news regarding medical devices in Ukraine. From February 24 Ukraine defends from the armed aggression of the Russian Federation; the country is under martial law. Every day the aggressor strikes civilian infrastructure with rockets. On July 4, 2022, the Office of the UN High Commissioner for […]