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
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
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 an informal chat with one of our experts.
Other content that might interest you:
The Centralized Procedure in the GCC Region describes the possibility to register pharmaceutical products throughout the region. The Cooperation Council for the Arab States of the Gulf, abbreviated as "GCC" for "Gulf Cooperation Council", came to exist on May 25th,...
EAEU legislation for Medical Device registration has been continuously updating for the last six years since the Eurasian Economic Union, otherwise known as EAEU, was entered into force in 2015. Five countries have signed the "Treaty on the Eurasian Economic Union" to...
Practical tips on Affiliate Based Outsourcing including for Regulatory Affairsoptimization of local RA setup, management and relevant costs.