News

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.

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.

We would like to inform you about significant changes in registration and quality management of medicinal products in Ukraine.
 

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.

EU recognition of certificates, remote audits and approvals in the interest of health: how certification of medical devices goes in a global pandemic

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.

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. 

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 each company and citizen.

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. 

On January 22, Order of the Ministry of Health of Ukraine No. 142 "On Approval of Methodological Recommendations on Application of Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013, Technical Regulations on medical devices for in vitro diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine No.