Medical device registration in Russia

In the Russian Federation all medical devices for use diagnostic and therapeutic purposes must be registered at the central department of the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor), which at the end of a process issued a certificate of registration under Resolution 1416.
Manufacturers must register devices with Roszdravnadzor prior to selling or distributing products.
Manufacturers must address substantial regulatory requirements, including:
  • preparing a technical file in Russian
  • conducting tests in local laboratories
  • submitting supplemental Russian clinical data, for some devices.
Maytal experts together with its partners located in Russian federation, can help medical devices manufacturer to navigate into Russian bureaucracy and language in an effective way.