roszdravnadzor seminars/webinars

Unregistered medical devices

Due to the activities of Roszdravnadzor (Federal Service for the Supervision of Public Health and Social Development) in Kaluga Region, the production and sale of unregistered medical devices has been discontinued. The General Director of the enterprise is brought to criminal liability in form of a penalty amounting to a quarter of a million rubles.

The Roszdravnadzor territorial body for Kaluga Region revealed, in the course of supervisory activities, the actual manufacturing and sale by Laser Academy of Sciences LLC (LAN LLC) of unregistered medical devices: diagnostic and surgical equipment, medical tools, orthopedic appliances and others.

All information about the activities of LAN LLC was transferred by Roszdravnadzor to the law enforcement agencies, the employees of which found out that during its life course, the organization sold 25 unregistered medical devices (laser therapeutic apparatuses) with the total cost of 1,852,700 rubles.

Upon consideration of the criminal case materials, Kaluga District Court found the General Director LAN LLC guilty of committing a crime stipulated for by clause b) of Article 235.1 of the Criminal Code of the Russian Federation and Part 1 of Article 238.1 of the Criminal Code of the Russian Federation, and imposed punishment in form of payment of a penalty totaling to 250 thousand rubles.