Introduction to Russia's Medical Device Approval Process

Russia is a promising market for medical devices, but the regulatory process can be challenging. The Russian regulatory authority, Rozsdravnadzor, prioritizes device testing and clinical data to verify device safety and efficacy. In this video, we provide a high level overview of the steps in the Russia medical device registration process, including:

  • Key players in the Russia regulatory system
  • Technical file documentation and language requirements
  • Testing and clinical data requirements
  • Phases of the regulatory review process
  • Final steps before importing your device

You'll learn all this and much more in this 6-minute video.