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
Regulatory Affairs Project Manager
Other content that might interest you:
How to register a Medical Device in the EAEU
Since the establishment of the Eurasian Economic Union in 2015, a significant change is quickly coming into life: a new regional registration system for medical devices is coming into effect from the start of 2022. As most registrations are completed through national...
How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?
Webinar: How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs? Affiliate-Based Outsourcing (ABO) Model for Regulatory Affairs works as a replacement or an extension of the company's internal and local RA resources, which are often insufficient for the...
Centralized Procedure in the GCC Region
The Centralized Procedure in the GCC Region describes the possibility to register pharmaceutical products throughout the region. The Cooperation Council for the Arab States of the Gulf, abbreviated as "GCC" for "Gulf Cooperation Council", came to exist on May 25th,...