Sep 16, 2020

Russia’s Ministry of Health (MoH) issued an order and two draft resolutions addressing the regulation of software as a medical device (SaMD). The changes work toward making SaMD regulation more rational and efficient, chiefly by following the approach developed by the International Medical Device Regulatory Forum (IMDRF) and used by numerous other regulatory bodies worldwide.

New MoH order introduces SaMD as distinct category in line with IMDRF recommendations

On August 10, the MoH published Order No. 686n of 07.07.2020, "On Amendments to Appendices No. 1 and No. 2 to the Order of the Ministry of Health of the Russian Federation No. 4n of June 6, 2012 ‘On Approval of the Nomenclature Classification of Medical Devices,’" which introduces a section dedicated to software as a medical device (SaMD). The outlined classification criteria and nomenclature outlined here are intended to harmonize with the IMDRF’s approach.

Draft resolutions propose further changes to incorporate SaMD

The MoH also drafted a resolution, “On Amendments to the State Registration of Medical Devices Regulations,” which proposes to incorporate SaMD into Order No. 1416n. The proposed changes are intended to lead to an accelerated procedure for new software products, including software that employs artificial intelligence technology.

Additionally, another drafted resolution, “On Amending the Requirements for the Content of Technical and Operational Documentation of the Manufacturer of a Medical Device, Approved by Order No. 11n of the Ministry of Health of the Russian Federation, Dated January 19, 2017,” proposes to introduce into the Russian regulatory system specific technical requirements pertaining to SaMD.

Learn more about medical device and IVD regulation in Russia:


  • Timothy Herr