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
- 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:
- Product Development
Duration: 50 minutes
Speaker: Mikhail Vinogradov, Regulatory Affairs Project Manager.
Mikhail Vinogradov, LLM
Regulatory Affairs Project Manager
Other content that might interest you:
Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products The webinar will highlight the practical tips and guide you through the crucial steps of marketing authorization upgrade to the Eurasian Economic Union (EAEU) one, ultimately leading you...
There is an increased demand for Materiovigilance solutions in recent years as the usage of medical devices keeps growing. Current industry changes are already impacting future developments, and it is becoming more and more challenging to keep up with recent...
Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization,...