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Inspections of the State Service of Ukraine on medicines and drugs control for COVID-19 IVD’s

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.

COVID-19: exemption from VAT, simplified procurement and registration, impact on regulatory

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.

Guidelines for medical devices and update of harmonized standards

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.