News

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 […]

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 […]

Ukraine has been defending itself from Russian military aggression for 20 days. The Armed Forces of Ukraine, territorial defense, and the population of Ukraine are holding back the advance of the aggressor. Russian troops are firing, launching rocket attacks, and bombing our cities, causing huge civilian casualties, destroying civilian infrastructure, and forcing millions of Ukrainians […]

We would like to express our huge gratitude to our partner Denk Pharma, manufacturer of high-quality pharmaceutical products from Bavaria, Germany that donated Ukraine 15 tons of vital medicines. The top management of Denk Pharma has made an immediate decision to support Ukraine according to the list provided by the Ministry of Health of Ukraine. […]

Ukraine is defending itself from the Russian military invasion. Russian forces are shelling and bombing cities, there are huge casualties among civilians.  At the same time, most of the regular supply channels of healthcare products are impacted: there are no public procurement procedures, regular supply channels are broken, some local manufacturers have stopped, some warehouses […]

On Thursday, Feb 24 at 5 o’clock in the morning, Russia has attacked Ukraine, simultaneously firing numbers of missiles on strategic objects, cities and invading troops to the territory of our country. We all woke up from the sound of explosions. Martial law was imposed in Ukraine from 05:30 on February 24, 2022 for a […]

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 […]