The Ministry of Health will update the procedure for the import of medical devices that are not subject to state registration
The Ministry of Health presented the draft rules for the import of medical products into Russia that are not subject to registration, as well as the procedure for issuing permits for the import of medical products for vital indicators for a particular patient. Legal entities or individual entrepreneurs included in the register of participants in the market for the circulation of medical devices, as well as organizers of international events for their needs, will be able to import medical devices. Data on each imported medical device must be entered into the automated information system (AIS) of Roszdravnadzor.
The first regulation will concern medical devices that are not subject to registration, which are manufactured in the EAEU for individual orders of patients for personal use, imported for research, including for scientific purposes, to provide medical assistance to participants in international cultural, sports events, expeditions and exhibitions, as well as imported styling, kits, kits and first-aid kits, consisting of registered medical devices.
Individuals, legal entities or individual entrepreneurs importing medical devices, as well as organizers of international events or exhibitions in case of import of medical devices for their needs, will have to enter data on imported medical devices in the AIS of Roszdravnadzor within three working days, including information on registration in the country of origin, model , serial number, information about the manufacturer, country of origin, place of production, configuration.
In addition, it is necessary to indicate the batch size, production date and expiration date, as well as the dates of the location of the medical devices in the territory of the Russian Federation and the deadline for their export or destruction for each medical device.
For imported medical devices, transportation, storage, installation, adjustment, use, operation, maintenance and repair, as well as disposal, destruction and export from the country are allowed.