Russia medical device QA/RA blog

News and commentary on regulatory changes.

In Brief: Russian Regulators Expand List of Implantable Medical Devices

EMERGO SUMMARY OF KEY POINTS:

  • Russian medical device regulators have updated their list of products that qualify as implantable medical devices.
  • Roszdravnadzor has added 160 new devices to the list of implantables. 

Russia updates to list of implantable medical devices 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.

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