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 […]

The rapid spread of coronavirus infection in Ukraine and all over the world prompts to review the existing testing protocols, to expand the capabilities of laboratories, and to look for new ways to identify and treat patients. According to the information announced by the Ministry of Health of Ukraine, an increase in the number of tests […]

Territorial bodies of the State Service of Ukraine on medicines and drugs control (market surveillance authority for medical devices) have started unscheduled inspections of the characteristics of medical devices for in-vitro diagnosis of acute respiratory disease COVID-19 caused by coronavirus SARS-CoV-2. These inspections will examine the legal entities listed in the Register of persons responsible […]

We would like to inform you about significant changes in registration and quality management of medicinal products in Ukraine.   1. Changes in the procedure for GMP recognition and certification. On July 21, 2020, amendments to the Order of the Ministry of Health of Ukraine of December 27, 2012 No.1130 «On approval of the Procedure […]