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.
The aim of this seminar 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.
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 of recent developments
Agenda:
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
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
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