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.