News

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 […]

On June 17, 2020, the IX Ukrainian Forum of Medical Device Operators was held, which traditionally discussed the most relevant topics related to taxation, prices and technical regulation of national medical devices market, personal protective equipment and disinfectants. In addition, for an actual understanding of the relationship between the international market of medical devices and […]

The pace and geography of the spread of coronavirus infection has been a source of tension for the world community for the several last months. Many countries have closed borders and restricted traffic within the country as preventive measures for the spread of COVID-19. At a time of acute need for medical devices, new challenges […]

Today the issue of the spread and prevention of coronavirus infection (COVID-19) is one of the most discussed and acute. World organizations and governments take active actions daily, relying on the relevant support from business.  In many countries where we operate, the mechanisms for simplified market access for medical products are introduced, duties and taxes […]

EU recognition of certificates, remote audits and approvals in the interest of health: how certification of medical devices goes in a global pandemic In February-March international passenger traffic was stopped in most countries and audits of medical devices manufacturers halted accordingly. But overcoming the pandemic requires meeting the demand for vital medical devices. How to […]