A larger number of products on the list of medical devices subject to preferential registration in Russia
Prime Minister Mikhail Mishustin signed decree No. 804 of June 2, "On changes regarding the preferential treatment of medical devices, including the state registration of a series (batch) of medical devices". The main purpose of the document was to introduce changes, in particular regarding trade in medical devices, to the decree approved on April 3, 2020 "On the characteristics of trade in medical devices, including the state registration of a series (batch) of medical devices".
The decree increases the number of medical devices on the list of products subject to simplified registration up to 363 types. After the amendment, the list will include devices and materials for laboratory diagnostics, medical furniture, refrigeration devices, respiratory circuits for ventilators, connectors and valves for mechanical ventilation, patient monitors, pulse oximeters, bronchoscopes, aspiration systems, bactericidal lamps and other medical devices. This is a great convenience for hospitals and other health facilities that need to urgently obtain the necessary equipment in the event of the need for mass hospitalization of patients in connection with the coronavirus epidemic.
The above-mentioned equipment will be able to get registered in accordance with the provisional, simplified registration scheme - in just three business days, and the Federal Health Surveillance Service, the so-called Roszdravnadzor, has also given permission to amend already submitted applications by means of a special additional application.
Furthermore, disposable medical devices included in the list attached to the decree, including laboratory diagnostic tubes, covers and protective visors, which have been registered and underwent certification outside the Russian Federation, may enter circulation bypassing the registration process, but only if that information on the number and series of imported medical devices will be forwarded to the Federal Health Surveillance Service. Without fulfilling this condition, they cannot be placed on the market.