On September 28, 2020, the Federal Service for Surveillance in Healthcare (Roszdravnadzor) announced the launch of a new digital service titled "Importation of Unregistered Medical Devices" on its official website.

As a reminder, Government Decree No. 430 dated April 3, 2020, "On the Specifics of the Circulation of Medical Devices, Including State Registration of a Series (Batch) of a Medical Device," permits the importation of unregistered medical devices into the Russian Federation until January 1, 2021, without obtaining prior authorization from Roszdravnadzor. This exemption applies to products specified in the annex to the decree, provided the volume is strictly limited to the amounts required for testing (trials), state registration, and subsequent commercialization. Furthermore, the decree allows the commercialization, transportation, storage, use, and disposal (destruction) of these single-use medical devices on the approved list, provided that such products have been duly registered in their country of origin.

The applicant must submit comprehensive data regarding the series (batches) of imported medical devices to Roszdravnadzor within three business days from the date of importation into the Russian Federation.

This digital platform specifically caters to these designated categories of medical devices.

The platform is accessible on the official Roszdravnadzor website under the "Electronic Services" section, specifically within the "Registration of Medical Devices" and "Importation of Medical Devices" subsections. The regulatory authority strongly recommends that entities utilize this online service to submit all information regarding the importation, commercialization, disposal, and exportation of unregistered medical devices.