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

A comprehensive In-house course 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.

In-house Training and Consultancy Services

The aim of this In-house course is to provide a comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. This interactive meeting will discuss the regulatory requirements within these regions. The focus will be on practical aspects to assist in developing your regulatory strategy for product approval in these countries. The presentations will also give practical hints on the regulatory and registration process where possible.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample Programme Day One - Russia

Russia – the competitive landscape

  • Current market and projected growth
  • Heath-2020 state program
  • Localisation of manufacturing
  • Pricing and reimbursement
  • Patent and data protection

National standards

  • Technical requirements and standards in key regions
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

Sample Programme Day Two - CIS and EAEU

CIS – Regional regulatory overview

  • CIS pharmaceutical market
  • CIS in International Regulatory Harmonisation
  • CIS regional regulatory co-operation – Eurasian Economic Union

Eurasian regulations for medical devices

  • Countries – members of EAEU, official bodies and terms of transition period
  • EAEU data requirements
  • EAEU registration procedures

Registration of medical devices in CIS

  • Common regional requirements in CIS:
    • Administrative data,translations, FSC, Dossier format, local Normative Document, samples, labelling
  • Country specific requirements: – Ukraine, Kazakhstan, Belarus, Moldova, Georgia, Armenia, Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan, Kyrgyzstan

Practical workshop

  • CIS Regional Regulatory Strategy

Recommended Trainer

Alex Dranov, M.D.R.A., is a native Russian speaker who was born in Ukraine. After graduating with honours in Biology/Biochemistry from Charkiw’s State University, he worked as a scientific employee at different pharmaceutical companies. Alex further enhanced his educational background by graduating in Business Administration from the University of Hagen and in Drug Regulatory Affairs with a Master’s degree (M.D.R.A.) from the University of Bonn. He has more than 20 years of regulatory experience in the pharmaceutical industry in Germany and Eastern Europe. Alex has managed multiple projects in the fields of regulatory affairs and product development. In 2010, he joined the International Division of Dr. Willmar Schwabe Pharmaceuticals, Germany, as a Senior Regulatory & Scientific Affairs Manager responsible for regulatory activities in and outside the EU, especially in Eastern European countries (Russia, Ukraine and CIS, among others), the Middle East and India.