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:
Local Affiliate Services That Deliver the Best Results
Find out how local affiliate services can reduce compliance risks and support effective regulatory strategies in the pharma industry.
Harmonizing Product Information Across Baltic Markets
Navigating multilingual product information across several markets can be complex – but it doesn’t have to be. In this case study, we share how one of our partner companies successfully harmonized their SmPC, PIL, and labelling across the Baltic region, working with...
Dossier Transformation for Market Expansion
Struggling with outdated dossiers and complex regulatory requirements? We partnered with a large pharma company to transform a fragmented legacy submission into a fully CTD-compliant dossier for successful market expansion in Europe. In this case study, we break down...