FAS (Federal Antimonopoly Service) Russia sent a warning to Roszdravnadzor to cancel the state registration of furniture as a medical device
By December 1, 2020, Rozdravnadzor needs to revise approaches to registering filing cabinets as medical devices and clear the state register of medical devices from household furniture
FAS Russia issued a warning to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) due to its inaction in resolving the issue of canceling the state registration of household furniture (filing cabinets) as medical devices.
The basis for sending the warning was an appeal that came to the Antimonopoly Office from the manufacturer of filing cabinets. Roszdravnadzor denied the applicant state registration of the designated product, since it does not belong to a medical device. At the same time, similar furniture from other competing manufacturers was previously included in the state register of medical devices.
According to the warning issued, Roszdravnadzor must:
– conduct an audit of all registration dossiers for document cabinets that have been registered as medical devices in order to establish that they have no signs of medical devices, as well as the impossibility of their use for medical purposes according to their functional purpose and (or) the principle of action;
– give assignments to the expert institution on the presentation of conclusions that would establish the fact of the possibility / impossibility of using such devices for medical purposes;
– if there are grounds to make a decision to cancel the state registration of the relevant products.
“The situation when household furniture that has no signs of a medical device is registered as such is unacceptable, since it creates discrimination between manufacturers of such“ pseudo-medical products ”and manufacturers of similar furniture that do not have Rozdravnadzor registration certificates: the former have competitive advantages by reducing the cost of their products in the amount of value added tax, and the latter are not able to participate in public procurement of furniture, if the customers indicate requirements for its state registration. The existing legislative framework allows the Federal Service for Surveillance in Healthcare to make appropriate decisions within the established powers”, stressed Maxim Degtyarev, Deputy Head of the Health Control Department of the FAS Russia.