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 […]

Not so long ago, the world community was shaken by the news about cases of pneumonia caused by an unknown pathogen, and today the issue of spread and prevention of coronavirus infection (COVID-19) is one of the most discussed and acute, both at the level of global organizations and states, and at the level of […]

Due to the rapid development of COVID-19 coronavirus infection, considering the safety and well-being of our colleagues and partners, we inform about the plans of our organization for the duration of the pandemic.  From March 16, 2020, for an indefinite period of time, Cratia has activated the Business Continuity Plan (BCP) aimed at minimizing risks […]