Nov 22, 2016
EMERGO SUMMARY OF KEY POINTS:
Russia’s medical device market regulator Roszdravnadzor has updated its list of products that qualify as implantable medical devices with 160 additions.
According to Emergo consultants in Moscow and The Hague, the Roszdravnadzor list was first published in 2014; in the updated version (link in Russian), some devices have been removed because they did not meet criteria established by the regulator’s latest nomenclature system.
Additional information on Russia’s medical device registration and approval system can be found by reading our whitepaper or downloading our regulatory process chart.
A new medical device nomenclature system launched and enforced by Russian regulators is causing challenges for registrants due to incomplete and missing codes, as well as more stringent requirements for grouping products together in the same registration.
Roszdravnadzor, the Russian medical device market regulator, has announced plans to develop a new device classification system based on Global Medical Device Nomenclature (GMDN), suggesting perhaps a regulatory approach more harmonized with international standards than previous Russian registration requirements.