Medical Devices in Russia and the Eurasian Union

Detailed programme Two broadcast sessions on 11 and 12 Nov 2020 9 - 12 am CET 09:00 Eurasia: The market for medical devices in Russia and its neighbouring countries

Political and economic review: Where does Russia and the Eurasian states stand?

What you should know about culture and cultural particularities

09:10 Dr Alexey Stepanov The Eurasian Economic Union (Overview)

Economic potential for medical devices

Market access and customs for non-EAEU members

The Eurasian Economic Medical Device Registration Rules (EER)

09:50 Break I
10:00 Market authorization

How does the Russian law for medical devices work? Also valid for EAEU members?

Nomenclature and classification of medical devices

More details, such as aim and objectives, about our
experts, who should attend, the time frame or how to
register and dial in an online course, can be found on
our website with the webcode 2107982!

10:50 Break II
11:00 Registration process of medical devices

Registration documents and declaration of

conformity (compulsory certification)

Documents for accreditation/certification

Change and amendments of registration dossiers

Change or duplicate of a registration certificates

Cancelation of a registration certificates

Import of samples/prototypes

Consequences of the increased VAT for foreign

importers

12:00 End of the first morning
09:00 Welcome and start of the 2nd session
09:05 Regulatory synergies from non-eurasian markets

Which documents can be used analogously from CE

certification or technical documentation?

If there are differences, which ones and what do I

need for a conformity?

How helpful is a STED file and what can be used

from other international approvals (e.g. 510 (k))?

09:45 Break I
09:55 Sergiy Kolesnichenko and Dr Alexey Stepanov Registration process of medical devices (Part II)

Change and amendments of registration dossiers

Change or duplicate of a registration certificates

Cancelation of a registration certificates

Import of samples/prototypes

Consequences of the increased VAT for foreign importers

10:45 Break II
10:55 Sergiy Kolesnichenko and Dr Alexey Stepanov Regulatory synergies from non-eurasian markets (Part I)

Which documents can be used analogously from CE certification or technical documentation?

If there are differences, which ones and what do I need for a conformity?

11:20 Sergiy Kolesnichenko and Dr Alexey Stepanov Regulatory synergies from non-eurasian markets (Part II)

How helpful is a STED file?

What can be used from other international approvals (e.g. 510 (k))?

11:50 Questions & answers or discussion round
12:00 End of the online seminar

Detailed programme Two broadcast sessions on 11 and 12 Nov 2020 9 - 12 am CET 09:00 Eurasia: The market for medical devices in Russia and its neighbouring countries

Political and economic review: Where does Russia and the Eurasian states stand?

What you should know about culture and cultural particularities

09:10 Dr Alexey Stepanov The Eurasian Economic Union (Overview)

Economic potential for medical devices

Market access and customs for non-EAEU members

The Eurasian Economic Medical Device Registration Rules (EER)

09:50 Break I
...