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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Russia and CIS - Regional Regulatory Overview
- Russia and CIS Market Overview
- Market protection policies
- CIS in regional and international
- Regulatory
- Harmonisation
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 MDs in Russia
- Regulatory authorities in Russia
- Key regulations governing registration process
- Clinical trials for medical devices
- National registration procedures
- Application dossier and data requirements
- Post approval life cycle maintenance applications
- Safety reporting and market surveillance
- Price and reimbursement
- Patent data protection
Common regional requirements in CIS
Administrative data, translations, normative document, samples, labelling
Registration of MDs in other CIS countries
- Other EAEU members: Kazakhstan, Belarus, Armenia, Kirgizstan
- EU harmonisation: Ukraine, Moldova, Georgia,
- National procedures: Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan
Workshop - CIS Regional Regulatory Strategy
