The Ministry of Health has developed a procedure for importing into Russia ‎ medical devices that are not registration subject

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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.