Successful Medical Device Registration in EAEU: New Legislation (Part 1)

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

Mikhail Vinogradov, LLM

Regulatory Affairs Project Manager Biomapas

Other content that might interest you:

Biosimilars in the MENA Region: Regulatory Landscape

Biosimilars in the MENA Region: Regulatory Landscape

Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several...

read more
Saudi FDA’s New Pricing Guidelines and Impact on the Region

Saudi FDA’s New Pricing Guidelines and Impact on the Region

In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.

read more

Big Enough To Cover  All Your Needs. Small Enough To Care.

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information