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

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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:

eCTD Submission Strategies: In-house vs. Outsourcing

Drugs serialization and barcoding in Saudi Arabia and MENA region

eCTD implementation across MENA region: What is the current status?

Regulatory Affairs Outsourcing: From Baby Steps in Cost Savings to Long-Term Partnerships

Rx to OTC Switches – 5 Things You Need to Know before Considering a Switch

Biomapas appoints Director Regulatory Affairs

The Predicted Impact of the ISO IDMP Standards Implementation Process Carried Out by the European Medicines Agency

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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Small Enough To Care.