The Resolution of the Government No.2129 dated the 30th of November, 2021, «On acceptance of the Regulations on licensing of maintenance of medical devices» is subjected to new changes. In this April, the correctives have been added that allow to reduce the costs of certification according to ISO 13485-2017. However, this time the Ministry of Healthcare insists on licensing of technical service of the medical equipment even for maintenance of own-made devices of the manufacturer.
At the same time, the quality management system and the requirements of the operational documentation won’t be considered as mandatory for the manufacturer to comply with. Other market participants can confirm compliance of the quality management system with the international standard ISO 13485-2017 or rules PP No.2129.
However, the medical devices use of which doesn’t presume regular technical service and repair and which don’t belong to any risk class can be inspected without a license.
It is also planned to extend the lists of the equipment with risk class 2а and 2b as it has been stated in April. The lists will include the medical devices for obstetrics and gynecology, the urological medical devices, the cardiovascular medical devices, the radiological medical devices including the ultra sonography scanners, the magnetic resonance imaging scanners, the devices for plastic surgery, dermatology, cosmetology, ophthalmology, physiotherapy, etc.
When accepted the corrective should come into legal force the 1st of March, 2023.