Control over circulation of medical devices on the territory of the Russian Federation is defined as a control over technical tests, toxicological studies, clinical trials, efficacy, safety, manufacture, production, sale, storage, transportation, import into the territory of the Russian Federation, export from the territory of the Russian Federation of medical devices, as well as over installation, checkout, administration, operating, including maintenance, repair, disposal and destruction.
The subject of the state control over the circulation of medical devices on the territory of the Russian Federation is the compliance of institutions with obligatory requirements in circulation of medical devices.
Control over circulation of medical devices is conducted by means of overseeing and supervision, including scheduled and unscheduled inspections of subjects of circulation of medical devices.
Enactment of Regulation of State Control over Circulation of Medical Devices is approved by the Resolution of the Government of the Russian Federation dated September 25, 2012 № 970 “On Approval of the Regulation on State Control over Circulation of Medical Devices”.
The procedure of execution of the state function of control with respect to legal entities and individual entrepreneurs engaged into activity on circulation of medical devices is specified by the Administrative Regulation of the Federal Service for Supervision over Public Health in Terms of Execution of the State Function for Control over Circulation of Medical Devices and is approved by the Order of Russian Federation Ministry of Health dated April 5, 2013 № 196н “On Administrative Regulation of the Federal Service on surveillance in healthcare in Terms of Execution of the State Function for Control over Circulation of Medical Devices” (reviewed on 01.11.2013) “.
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