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

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

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 International Regulatory Harmonisation
• CIS regional regulatory cooperation – 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

Workshop: CIS Regional Regulatory Strategy