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.
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.
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.
Outside the European Union, regulatory responses to the pandemic are emerging from Norway, Iceland, Switzerland, and Russia.
The US Food and Drug Administration has called for test cases from developers for its nascent Pre-Cert certification program for software as a medical device (SaMD).
EMERGO BY UL SUMMARY OF KEY POINTS:
On August 25, 2016, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued a guidance covering “Medical device stand-alone software including Apps.” The guidance is applicable to the current medical device directives 93/42/EEC and may be replaced when the new EU Medical Device Regulations are put into force.