Single market of medical devices and IVD products within EEU (ARM, BEL, KAZ, KGZ, RUS). Future changes


Medical device and IVD product registration in Russia


Medical device and IVD product registration in Russia


50 min + 10 min. Question Time


Prerequisite: basic knowledge of medical devices



-Transition period clarification,

-legislation base,

-Essential requirements to safety and performance,

-Applied classification,

-Basic understanding of registration process,

-Quality Management System requirements,

-Safety monitoring (surveillance),

-Comparison of current registration in Russia and EEU procedures,

-Critical points of single market.

Who Will Benefit:


  • Quality Manager
  • Quality Engineers
  • Design Quality
  • Regulatory Affairs specialist
  • Medical Affairs specialist
  • Clinical Affair specialist
  • R&D Engineers
  • Marketing


Certification Requirements:

Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.


Online Training Programs Includes:

  • Answer to questions submitted during the webinar.
  • An online final assessment with multiple choice questions.
  • A Certificate of Completion.