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State Medical Service starts unscheduled inspections of medical devices intended for in vitro diagnostics COVID-19

The State Service of Ukraine for Medicinal Products and Drug Control (hereinafter – the State Medical Service) informs that the territorial bodies of the State Medical Service have started unscheduled inspections of the characteristics of introduced products intended for in vitro diagnosis of acute respiratory disease COVID-19 caused by SAR.

In particular, the entities listed in the Register of Persons Responsible for the Placement of Medical Devices, Active Implantable Medical Devices, and In-vitro Diagnostic Medical Devices will be inspected.

Employees of territorial bodies of the State Medical Service of other oblasts are involved in conducting inspections of business entities located in Kyiv and the Kyiv region.

Additionally

In accordance with paragraph 23 of the Technical Regulations for Medical Devices for In Vitro Diagnostics, it is determined that a manufacturer who places a product under its name must inform the State Medical Service about its location, reagents, reagent products, calibrators, control materials, and any -what significant changes, including the fact of cessation of the introduction of medical devices into circulation.

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