Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

Webinar: Medical Device Registration in the Eurasian Economic Union (EAEU)

The webinar on Medical Device Registration in the Eurasian Economic Union (EAEU) reviews the practical aspects of the approval procedure. We will discuss the various stages of the registration process and conformity assessment routes for different risk classes. In addition, you will learn about the testing process and the new approach to clinical trials.

This webinar focuses on learning:

 1. EAEU Conformity Assessment Routes for Medical Devices

  • Stages of the Registration Process
  • Risk Classes and Conformity Assessment Routes
  • Testing
  • Clinical trials

2. EAEU Mutual Recognition Procedure for Medical Devices

  • Reference Countries, Concerned Countries, and Recognition Procedure
  • Current situation

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

 

Registering your medical device in the EAEU?

Explore your options in an informal chat with one of our experts.

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

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