FORUM INSTITUT
FORUM · Institut für Management GmbH
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69115 Heidelberg
Email: service@forum-institut.de
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Medical Devices in Russia, the Ukraine and in the EEC
Medical Devices
in Russia & the EAEU
For professionals who want to know all future changes
and how to overcome the regulatory hurdles
2020-02-27 2020-02-27 NH Frankfurt Airport West Kelsterbacher Str. 19-21 65479 Frankfurt-Raunheim nhfrankfurtairportwest@nh-hotels.com +49 6142 990-0 +49 6142 990-100

Medical Devices in Russia and the Eurasian Economic Union

Recent challenges in market authorization and maintenance of medical device approval

This course provides you with sound knowledge in dealing with the registration and distribution of medical devices in Russia, Belarus, Kazakhstan and many other countries.
Your Topics
  • Current and new regulatory framework in Russia and the EAEU
  • How you can also benefit from the changes made by the European MDR for Russia and the EAEU
  • Successfully complete a registration and certification process
  • Mandatory documents and certificates
  • Management of changes and amendments of dossiers
  • How to treat an authority in the right way

This distinguishes our event

100%
Overall impression: 100 % of the participants' feedback was very good or good. (February 2017)
87,5%
Course content: 87,5 % of the participants' feedback was very good or good.. (February 2017)
87,5%
Practical benefit: 87,5 % of the participants' feedback was very good or good. (February 2017)

Aims and Objectives

Starting January 2016, common regulations set by the Eurasian Economic Commission (ECC) for the system for medical devices came into force (the Eurasian Economic Medical Device Registration Rules/ERR).

This new regulatory framework intended to harmonize the requirements between countries like Belarus, Kazakhstan and Russia and establish a common market. The current transition period ends 2021.

Our course gives you a detailed overview of the current legal framework and the medical device approval in Russia and the member states of the EAEU as customs union.

An essential part will be to explain to you how you can use regulatory efforts, which you can currently use for compliance according to the European Medical Device Regulation, also for product approvals in Russia and EAEU states. In addition, our team of speakers will show you how, as a globally active medical device company, you can use synergy effects from other markets to successfully complete an Eurasian registration.
Who should attend
This course aims at healthcare professionals who wish to export or renew medical devices to Russia and the Eurasian Economic Union. Those involved in:
  • regulatory and quality affairs
  • product management and marketing
  • market access and sales
  • export and business development
will particularly benefit from the speakers' first-hand expertise.

This course is in English.
Referenten
Dr. Edelgard Rehak
Dr Edelgard Rehak Consulting, Storkow, Germany

Dr Alexey Stepanov
Regulatory Affairs Manager for Medical Devices and In vitro Diagnostics in Russia and the Eurasian Union in a global healthcare company


Go forward

Medical Devices Eurasia

Eurasian Governments issue new harmonized Medical Device Regulations

Governments of five Eurasian countries have issued final regulations to establish a harmonized regulatory system for medical devices and IVDs across their respective jurisdictions.

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Russian Healthcare

Russian Healthcare System

In recent years, Russia’s economic instability has increased due to rapidly falling oil prices, causing a spike in poverty and decreasing investments in infrastructure, such as healthcare. Though the Russian economy began its recovery in 2017 with a GDP increase of 1.5 percent, this is not significant enough to improve Russian quality of life or provide more funding for healthcare, which has led to a Russian healthcare crisis.

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More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards. An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2016 - 09.2017 produced a result of 1.6 (where 1 is the highest grade and 6 the lowest).

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