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:
Company Registration Requirements in MENA: a Prerequisite for Product Registration
Company registration is part of the common regulatory requirements in several Middle Eastern and North African (MENA) countries. Nevertheless, it can be easily overlooked in preparation for drug filing and the overall regulatory picture. MENA countries are accepting...
Biosimilars in the MENA Region: Regulatory Landscape
Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several...
Successful Medical Device Registration in EAEU: New Legislation (Part 1)
Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1) The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and efficacy assessments, and...
