Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1)
The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and efficacy assessments, and compares the EAEU system, current national registrations, and EU Medical Device Regulation (MDR).
This webinar focuses on learning:
1. EAEU Legislation on Medical Device registrations
- Legislation structure and comparisons
- Safety and Performance requirements
- Transition period updates
2. EAEU Registration Dossier
- Dossier structure and new changes
Eurasian system for medical device registration will come into force on January 1st, 2022, and will fully replace all national systems of the EAEU member states.
Registering Your MD In The EAEU?
Make use of our experience to facilitate the approval process. Explore your options in a 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 Biomapas
Other content that might interest you:
Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation
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...
Download – ABO Whitepaper
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,...
What is the Clinical Trials Regulation?
The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By implementing this Clinical Trials Regulation (CTR) early 2022, the European Commission hopes to establish a better environment for clinical trials in the...
