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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.

These inspections will examine the legal entities listed in the Register of persons responsible for the placing on the market of medical devices, active implantable medical devices and medical devices for in-vitro diagnostics. 

LLC “Cratia Medtekhnika” provides outsourcing services of an Authorized Representative for foreign manufacturers of medical devices and medical devices for in-vitro diagnostics. 

The quality management system of LLC “Cratia Medtekhnika” is certified by Bureau Veritas (Italy) in accordance with the international standard ISO 9001.

LLC “Cratia Medtekhnika” is one of the first companies to successfully pass the inspection of the State Service of Ukraine on medicines and drugs control as the Authorized Representative of EU and US manufacturers for medical devices for in-vitro diagnostics of COVID-19.

There were found no observations or non-conformities; quality, safety and compliance of products with the requirements of the Technical Regulation have been confirmed. 

Be healthy and take care of yourself!