The Ministry of Health of Russia has developed and put up for public discussion on the official portal regulation.gov.ru a draft decree of the Government of the Russian Federation, which approves the procedure for importing medical devices that are not subject to registration into Russia.
It is expected that the document will enter into force on September 1, 2021 and will be valid until January 1, 2027.
In accordance with Russian legislation and international treaties and acts constituting the law of the Eurasian Economic Union (EAEU), medical devices are not registration subject:
made in the territory of the EAEU member according to individual orders of patients exclusively for personal use and for which special requirements are imposed in accordance s the appointment issued by the medical worker;
imported into the customs territory of the Union for research, including for scientific purposes;
imported into the customs territory of the Union to provide medical assistance to participants in international cultural, sports events i participants in international expeditions, as well as for exhibitions;
imported into the customs territory of the Union as humanitarian assistance in cases determined by the legislation of member States;
imported into the territory of the Russian Federation to provide medical care according to the vital indications of a particular patient based on a permit issue by Roszdravnadzor.
