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:
Saudi FDA’s New Pricing Guidelines and Impact on the Region
In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of pharmaceutical products. What followed is a change in the pricing strategy by SFDA and a shift from price takers to price makers.
Marketing pharmaceutical products in CIS countries / Eurasion Union
The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs,...
Regulatory Strategy in the EAEU and rest of CIS Countries
Webinar: Regulatory Strategy in the EAEU and Rest of CIS Countries Regulatory strategy in EAEU and CIS regions differ from other regions as market access to these countries can be a real challenge due to various local regulations. However, it is only a matter of...