The Russian government has updated the rules for the import of non-registration Medical Devices
The government of the Russian Federation has approved changes to the rules for the import of medical products into Russia that are not subject to registration. The regulation requires market participants to enter data on each imported medical device into the automated information system (AIS) of Roszdravnadzor. The updates will take effect from March 1, 2022 and will be valid until January 1, 2027.
The procedure regulates the import of medical devices that are not subject to registration, manufactured in the EAEU by individual orders of patients for personal use, imported from abroad 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.
The draft of the profile decree of the Government of the Russian Federation was developed in May 2021. At the same time, the Ministry of Health presented a draft rules for issuing permits for the import of medical products for the provision of medical care to a specific patient in terms of vital signs. It is assumed that the application will be submitted through the portal of public services in electronic format, it must include information about the imported medical device, including a copy of operational documentation, color photographs of the medical device along with accessories, information about the registration certificate in the country of production, batch size, batch number, model, place of production. The regulator will make a decision within five working days.