Order of the RF Ministry of Healthcare No.661н dated the 30th of July, 2020, presumes receiving an official permission for importation of samples of non-registered medical devices to be further registered on the territory of Russia . However, with regards to the present situation, the Federal Service for Surveillance in Healthcare informs that importation will for now require only a notification.
Such a facilitation corresponds to the policy of the so-called regulatory guillotine and is supported by resolution No.336 dated the 10th of March, 2022, that specifies the peculiarities of inspections in the current year.
The Federal Service for Surveillance in Healthcare published the corresponding letter No.04и-879/22 on its web-site on the 8th of August.
Now, the manufacturers of medical devices need just to send a notification letter on importation of a sample of a medical device to be registered according to the established order to the Service. The internet portal «State Services» («Gosuslugi») provides an ability to send an electronic document confirmed by a qualified electronic signature.
