Medical Devices in Russia and the Eurasian Economic Union
Recent challenges in market authorization and maintenance of medical device approval
- 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
Aims and ObjectivesStarting 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.
- regulatory and quality affairs
- product management and marketing
- market access and sales
- export and business development
This course is in English.
- Political and economic review: Where does Russia and the Eurasian states stand?
- What you should know about culture and cultural particularities
- Economic potential for medical devices
- Market access and customs for non-EAEU members
- The Eurasian Economic Medical Device Registration Rules (EER)
10:30 Coffee break
- How does the Russian law for medical devices work? Also valid for EAEU members?
- Nomenclature and classification of medical devices
12:30 Lunch break
- 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
15:30 Coffee break
- Which documents can be used analogously from CE certification or the technical documentation? If there are differences, which ones and what do I need for a conformity?
- How helpful is a STET file?
- What can be used from other international approvals (e.g. 510 (k))?
16:45 Questions & Answers
17:00 End of seminar
Dr Rehak is an expert on registration in Russia and Central and Eastern Europe. From 2011 to 2014, she worked as Regulatory Director at Sanofi and Medical Director at Zentiva, based in Moscow, and prior to that, from 2006 to 2009, as Head Regulatory and QA for Novartis, based in Kiev, Ukraine. She has a broad range of experience in bioequivalence and toxicological trials in Russia. Until 2006, she held several positions in product development (Gx and biosimilars) and clinical research at Sandoz/HEXAL, Germany.
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Dr. Stepanov studied medicine at the first Moscow State Medical University I.M. Sechenov. He worked for many years in international medical device companies and has thereby solid regulatory experiences and proven track records of class I-III medical devices approved in Russia and CIS countries. Furthermore Dr. Stepanov has intensive experience in quality management and carries the Six Sigma yellow belt. Currently he works for a large global healthcare company as Regulatory Affairs and IVD expert, has broad knowledge of global medical device regulatory trends and feeds his own block regularly about Medical Device Regulations in Russia and the Eurasian Union.
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Phone: +49 6142 990-0
Fax: +49 6142 990-100
... the legislation for the registration and circulation of medical devices is changing significantly, under pressure from the Customs Union. This seminar provides you with in-depth knowledge on the current challenges when applying for a new marketing authorization and an overview of maintenance activities in the EAEU countries like Russia or Belarus.
For better communication and understanding, this course is undertaken in English.
Richard Wolf GmbH, Manager Regulatory Affairs
Guter Praxisnutzen, kleiner Teilnehmerkreis
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