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:

Unlock the full potential of your medical writing outsourcing

Unlock the full potential of your medical writing outsourcing

When clinical timelines are tight and regulatory expectations keep shifting, outsourced medical writing becomes a competitive edge. The right medical writing CRO can help you scale document production, stay aligned with evolving compliance standards, and bring your...

read more
Choosing the Right QPPV Partner for EU and Global Compliance

Choosing the Right QPPV Partner for EU and Global Compliance

Pharmacovigilance outsourcing has become crucial for biotech companies to remain compliant and safeguard patients. When you bring a drug to market in Europe or globally, your Qualified Person for Pharmacovigilance (QPPV) serves as your first line of defense. The right...

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

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

Discover how Biomapas provides all the support to accelerate your clinical trials and optimize your drug development process.

Clinical Research

Reliable support for every phase of your clinical trial, from recruitment to results.

Pharmacovigilance

Flexible safety monitoring to keep your products compliant and trusted.

Regulatory Affairs

Confidently navigate regulatory challenges with expert support.

Medical Information

Clear, accurate medical information 24/7, tailored for global audiences.

Quality Assurance

Export auditors help identify gaps and close them with actionable solutions.