RUSSIA – HealthCare System and

Medical Regulation Seminar



March  20th , 2018 


Israel Export Institute, Hamered 29 st., Tel Aviv

09:00 - 12:00, "Israel" Conference Hall, 5th Floor


Prediction assume... there is no better time to start learning the Russian HealthCare System, before setting a footprint.


Seminar Agenda


09:00                 Registration…  Gathering…  Networking 

09:15                 Welcoming & Introduction

09:20 – 10:00    PART I

  • Size, Facts & Figures 
  • Governmental bodies involved  and  Key Players
  • Interconnection between Private and Governmental sectors  
  • National manufacturers vs Importation
  • Competitive advantages of Products and Technologies, considering demand, lack of technology, etc;
  • Pricing & Reimbursement system
  • Insurance coverage
  • Private purchasing (main medical area and mechanisms)
  • Government purchasing (predominant fields)

          What sectors / diseases are increasing health expenditure;

          What factors push new technology acquisitions


10:00 – 10:15   break


10:15 – 11:00   PART II

Medical device and IVD product registration in Russia. Current procedure»

  • Basic registration analysis
  • Legislation framework
  • Classification rules
  • Registration process depending on risk class
  • Documents from manufacturer site
  • Basic understanding of pre-clinical and clinical trials
  • Duplicates and amendments of/in existing registration certificate
  • Declaration issues

11:00 – 11:15   break


11:15 – 12:00   PART III

Single market of medical device and IVD product within Eurasian Economic Union (RUS, BEL, KAZ, ARM, KYG). Expected changes»

  • 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 point of single market

**The seminar will be presented in English


14:00 – 17:30      Potential One-on-One Meeting with the Speakers

**The approval of the meetings is to be determined by the speakers and will require registration and attendance in the seminar - Follow the link to apply

BeAWire Speakers
  • Ruslan Kalachev , Development Director in BeAWire Regulatory Affairs Agency; ASQ member; RAPS member; co-founder Test ME.
  • Tatiana Nosova , CEO in BeAWire Regulatory Affairs Agency which is highly specialized on medical device and IVD product registration in Russia. 

**Speakers Bio’s in the  link



Participation Fee:
IEI Members:  180NIS
Non IEI Member: 300NIS

For more information, contact:




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