Medical Devices in Russia and the Eurasian Economic Union - Recent challenges in market authorization and maintenance of medical device approval

Kurs

In Frankfurt

Preis auf Anfrage

Beschreibung

  • Kursart

    Kurs

  • Ort

    Frankfurt

  • Dauer

    1 Tag

  • Beginn

    nach Wahl

- 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

Standorte und Zeitplan

Lage

Beginn

Frankfurt (Bayern)
Karte ansehen
Dreieichstraße 59,-60594 Frankfurt]

Beginn

nach WahlAnmeldung möglich

Hinweise zu diesem Kurs


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.

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Meinungen

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2020

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Die Durchschnittsbewertung liegt über 3,7

Mehr als 50 Meinungen in den letzten 12 Monaten

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Inhalte

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.

Medical Devices in Russia and the Eurasian Economic Union - Recent challenges in market authorization and maintenance of medical device approval

Preis auf Anfrage