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.

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Make use of our experience to facilitate the approval process. Explore your options in a chat with one of our experts.

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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

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

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

1. EAEU Legislation on Medical Device registrations

2. EAEU Registration Dossier

Registering Your MD In The EAEU?

Mikhail Vinogradov, LLM

Other content that might interest you:

Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

Affiliate Based Outsourcing for Regulatory Affairs

Company Registration Requirements in MENA: a Prerequisite for Product Registration

A History of Pharmacovigilance

Developing a Safety Management Plan (SMP) for Pharmacovigilance

EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures?

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

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

1. EAEU Legislation on Medical Device registrations

2. EAEU Registration Dossier

Registering Your MD In The EAEU?

Mikhail Vinogradov, LLM

Other content that might interest you:

Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

Affiliate Based Outsourcing for Regulatory Affairs

Company Registration Requirements in MENA: a Prerequisite for Product Registration

A History of Pharmacovigilance

Developing a Safety Management Plan (SMP) for Pharmacovigilance

EMA & FDA: What Are the Similarities & Differences in Risk Management Procedures?

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

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

Clinical Trials

PV System & QPPV

Post-Authorization

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