The official website of the Federal Service for Surveillance in Healthcare on September 28, 2020 contains information on the launch of the electronic service “Import of unregistered medical devices”.
Recall that the Decree of the Government of the Russian Federation of 03.04.2020 No. 430 “On the peculiarities of the circulation of medical devices, including state registration of a series (batch) of a medical device” established that until January 1, 2021 it is allowed to import unregistered medical products according to the list attached to the specified legal act (to the extent necessary for testing (research), state registration and subsequent sale). It is also allowed to sell, transport, store, use and utilize (destroy) the specified disposable medical devices according to the approved list, if these products are registered in the established manner in the manufacturing country.
The applicant is obliged, within 3 working days from the date of importation of unregistered medical devices into the Russian Federation, to send to the Federal Service for Surveillance in Healthcare information on the series (consignments) of imported medical devices.
This service is intended specifically for the specified categories of medical devices.
The service is posted on the official website of Roszdravnadzor in the section “Electronic services”, subsection “Registration of medical devices” and “Import of medical devices” and the agency recommends information about the import of unregistered medical devices, their sale, disposal and export, should be sent through the specified service.
