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:
- Regulatory
- R&D
- QA/QC
- Compliance
- Product Development
- Manufacturing
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:
Let’s celebrate success
Recently, we had the chance to reflect on our last 10 years of operations and were astonished by the unprecedented growth facts: The Clinical Research department grew 8 times the size it was back in 2013. Regulatory Affairs services became available to 32 new...
How can a CRO support Mergers & Acquisition
The role of Contract Research Organizations (CROs) in supporting mergers and acquisitions (M&As) is not a new concept, as CROs have been providing services in this area for several years. However, the demand for these services may have increased in recent years...
The Role of Regulatory Intelligence in Pharmacovigilance
Regulatory Intelligence is a reliable and invaluable tool when it comes to pharmacovigilance. It's so important because it allows companies to remain up-to-date with the most recent drug safety data and identify new information quickly. What Is Regulatory...
