Webinar: Successful Medical Device Registration in Russia. The Essentials
The current national system for Medical Device registration in Russia was created from scratch and entered into force in 2013. Most experts agree that this system is complex and puzzling – some critical points are not well documented, some regulatory requirements are ambiguous and unwritten rules play an essential role during the process.
The purpose of this webinar is to explain the Medical Device registration procedure in Russia.
You will learn about:
- Russian Competent Authorities in the medical device field
- State Legislation and levels of legislation
- The scheme of State registration
- The registration dossier and list of the documents
- Testing and evaluation (technical, toxicological, clinical)
- Post-registration activity
- Role of an Authorized Representative of the manufacturer
Expanding into the Russian market?
Make use of our experts to guide you from the start to a full market access. Explore your options in a chat with one of our experts.
Who should attend? Professionals from Medical Device companies working within:
- Product Development
Duration: 50 min.
Speaker: Regulatory Affairs Project Manager, Mikhail Vinogradov, LLM, who will share his experience on registering Medical Devices in Russia.
Mikhail Vinogradov, LLM
Regulatory Affairs Project Manager
Other content that might interest you:
Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products The webinar will highlight the practical tips and guide you through the crucial steps of marketing authorization upgrade to the Eurasian Economic Union (EAEU) one, ultimately leading you...
There is an increased demand for Materiovigilance solutions in recent years as the usage of medical devices keeps growing. Current industry changes are already impacting future developments, and it is becoming more and more challenging to keep up with recent...
Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization,...