Due to Federal Law dated November 21, 2011 №323 –FZ “On Fundamentals of Healthcare of the Citizens in the Russian Federation” and the Resolution of the Government of the Russian Federation dated May 2, 2012 № 413 the Federal Service on surveillance in Healthcare is vested with powers to monitor safety of medical devices which are in circulation on the territory of the Russian Federation.
In compliance with Article 96, paragraph 1 of the Federal Law dated November 21, 2011 № 323- FZ “On Fundamentals of Healthcare of the Citizens in the Russian Federation”, medical devices in circulation on the territory of the Russian Federation are subject to safety monitoring in order to reveal and to prevent side effects inconsistent with the information contained in a package leaflet or a manual for a medical device, of adverse reactions that occurred when administering a medical device, of peculiarities of interaction of a medical device with other medical devices, of facts and circumstances creating threats to life and health of citizens and medical workers due to administration and operation of medical devices.
Subjects of circulation of medical devices must inform Roszdravnadzor of any cases of side effects inconsistent with the information contained in a package leaflet or a manual for a medical device, of adverse reactions that occurred when administering a medical device, of peculiarities of interaction of a medical device with other medical devices, of facts and circumstances creating threats to life and health of citizens and medical workers due to use and operation of medical devices.
If the threat to citizens’ life and health is confirmed, Roszdravnadzor requests the manufacturer of a medical device to present information of any other cases of adverse events involving this medical device as well as documents confirming compliance of this medical device with quality requirements (including results of internal investigation).
If the results of examination of the information presented confirms the threat to citizens’ life and health, Roszdravnadzor makes a decision on suspension of circulation of a medical device, on taking supervisory measures with respect to a medical institution, where the revealed events occurred and/or to a manufacturer and on selection of samples of this medical device.
In a case the incompliance of medical devices with the requirements established by Roszdravnadzor was confirmed during supervision, Roszdravnadzor makes a decision on withdrawal of such medical devices from circulation and places information letters on the official web-site of the Federal Service on surveillance in healthcare. You can find these letters in the section “Documents”.
