From July 1, 2021, the Regulation on federal state control (supervision) over the circulation of medical devices comes into force
Federal state control is exercised by Roszdravnadzor and its territorial bodies.
The objects of control are: the activities of legal entities and individual entrepreneurs in the field of circulation of medical devices; the results of the activities of the controlled persons; buildings, premises, structures and equipment to which mandatory requirements are imposed.
Objects of state control are categorized by risk groups (significant, medium, moderate and low risk) based on established criteria.
Taking into account the risk group, the frequency of scheduled control activities is established.