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Medical Device Regulation in the Eurasian Union, Russia and the CIS

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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About this programme

The aim of this event is to provide a comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. This interactive course will cover the regulatory requirements within these regions, focusing on practical aspects to assist in developing your regulatory strategy for product approval. The presentations will also give practical hints on the regulatory and registration process where possible.

Benefits of attending

Attending this programme will:
  • Give you the full background to the CIS medical device market
  • Ensure that you understand the full implications of the new regulations which will affect how you do business in the Eurasian Economic Union (EAEU)
  • Help clarify the document requirements and timelines of national procedures and EAEU registration procedures
  • Fully update you on the national regulations in Russia, Belarus, Kazakhstan, Ukraine and other CIS countries

Who should attend?

This seminar will be of particular interest to:
  • Personnel working in medical device regulatory affairs in this region
  • Anyone who is considering marketing a medical device in this region
  • Those interested in an update on recent developments


CIS – regional regulatory overview

  • CIS and Russia Market Overview. Market protection policies
  • CIS in regional and international Regulatory Harmonisation

Common regional requirements in CIS

  • Administrative data, translations, FSC, dossier format, local normative document, samples, labelling

Eurasian regulations for Medical Devices

  • Countries current members of EAEU and EAEU Official bodies
  • Terms of transition period
  • EAEU Registration Procedures. Application process
  • EAEU submission documents and data Requirements
  • QMS inspections

Registration of Medical Devices in Russia

  • Regulatory authorities in Russia and key bodies
  • Key regulations governing registration process
  • Clinical trials for medical devices
  • Registration procedures – what is required?
  • Application dossier and data requirements
  • Post-approval life cycle maintenance applications
  • Safety reporting and market surveillance

Registration of Medical Devices in other EAEU countries

Kazakhstan, Belarus, Armenia, Kirgizstan

Registration of Medical Devices in other CIS countries

  • EU sphere of influence: Ukraine, Moldova, Georgia,
  • Independent National procedures: Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan

Workshop: CIS Regional Regulatory Strategy


Anna Harrington-Morozova (More...)

Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained working in a Regulatory Authority, academia and industry. Anna graduated in Russia as a pharmacist. After working in the Russian Ministry of Health and the Clinical Pharmacology Department of Moscow Medical University, she held regulatory and external relation positions in the pharmaceutical industry and CROs in Russia and the UK, including senior regulatory affairs posts in GSK,EISAI, ICON and PRA. Anna currently acts a a Scientific and Reguatory director at Regem Consulting Ltd – a consultancy which focuses on drug development, global regulatory advice, professional trainings and flexible resourcing solutions for the pharmaceutical, biotech and medical device industries in emerging markets.


Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 12-13 Apr 2022
  • 5-6 Jul 2022
  • 12-13 Oct 2022

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Previous customers include...

  • Abbott Diabetes Care
  • ArjoHuntleigh AB
  • Biomet UK Healthcare Ltd
  • Biotronik AG
  • Brainlab AG
  • Cepheid
  • DKT Woman Care
  • Fidia Farmaceutici S.p.A.
  • HemoCue AB
  • Horus Pharma
  • JSC Thermo Fisher Scientific
  • LiNA Medical Polska Sp. z o.o.
  • Mölnlycke Health Care AB
  • Nobel Biocare
  • Research and Markets
  • Rodenstock CR s.r.o.
  • Santen Oy
  • Septodont
  • Thermo Fisher Scientific
  • William Cook Europe ApS

My opinion is overall very positive. I liked how the content was delivered and the knowledgeable speaker.

Monica Fabris, Regulatory Affairs Expert, Fidia Farmaceutici S.p.A., Oct 20


Helen Finn, Regulatory Affairs Coordinator, ArjoHuntleigh, Oct 17

Content is very good. Speakers are also well prepared and competent

Anette Hulstrøm, Specialist Regulatory Affairs, William Cook Europe ApS, Oct 17