News

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; […]

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 highlight the most important regulatory news regarding cosmetics, food products and disinfectants (biocides). Since February 24, Ukraine has been defending itself from the russian invasion, the country is under martial law. Every day the aggressor’s troops launch rockets on civilian infrastructure. On September 4, 2022, the Office of the UN High Commissioner for Human […]

Cratia has traditionally become the general sponsor of the 11th Ukrainian Forum of Medical Devices Market Operators. This important annual event provides a platform for manufacturers, suppliers, distributors and importers of medical devices to address all pressing issues and share valuable business experience, especially during martial law. As part of this event, Maksym Bagreev, managing partner […]

This year, the 11th Ukrainian Forum of Medical Devices Market Operators provided manufacturers, suppliers, distributors, importers of medical devices with a platform to resolve all pressing issues, discussions, recommendations and share valuable business experience during martial law. Cratia as the general sponsor of this event, and it’s managing partner Maxim Bagreev made a presentation “The transition […]

We previously informed that the Ministry of Health of Ukraine by letter dated February 25, 2022 No. 24-04/5396/2-22 allowed the placing of the medical devices on the market of Ukraine without meeting the requirements of the Technical Regulations, and also allowed the labeling of such medical devices without meeting the requirements of the Law of […]