Registration of MD and IVD products in Russia and EAEU

BW announces the webinar will be held on 21th of December from 12:30 p.m to 02:30 p.m.(Moscow time).


12:30-01:30 «Registration of medical devices and IVD products in Russian (current procedure)»

  • Basic registration analysis,
  • Legislation framework,
  • Classification rules,
  • Registration process depending on risk class,
  • Documents from manufacturer side,
  • Basic understanding of pre-clinical and clinical trials,
  • Declaration issues.

01:30-02:30 «Single market of medical devices and IVD products within Eurasian Economic Union (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 points of single market.

For details please contact to Ruslan Kalachev:; +7(499)281-67-68 ext. 101.