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Successful Medical Device Registration in EAEU: New Legislation (Part 1)

MD registration in the EAEU

Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1)

The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and efficacy assessments, and compares the EAEU system, current national registrations, and EU Medical Device Regulation (MDR).

This webinar focuses on learning:

1. EAEU Legislation on Medical Device registrations

  • Legislation structure and comparisons
  • Safety and Performance requirements
  • Transition period updates

2. EAEU Registration Dossier

  • Dossier structure and new changes

Eurasian system for medical device registration will come into force on January 1st, 2022, and will fully replace all national systems of the EAEU member states.

 

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Who should attend?

Professionals working in the following fields:

  • Regulatory
  • R&D
  • QA/QC
  • Compliance
  • Product Development
  • Manufacturing

Duration: 50 minutes

Speaker: Mikhail Vinogradov, Regulatory Affairs Project Manager

Mikhail Vinogradov, LLM

Mikhail Vinogradov, LLM

Regulatory Affairs Project Manager Biomapas

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