Webinar: Medical Device Registration in Russia. Challenges and Issues
The purpose of this webinar is to show the differences and specifics of regulations and law processes that can cause challenges in medical device registration in Russia.
You will learn about:
1. The specificity of national classification of medical devices
- What is a Medical Device and what is not a Medical Device?
- Why some medical products are medical devices in the EU but not considered as medical devices in Russia?
2. Key issues with the registration of complex and multi-component medical devices
- Complex IVD Systems
- Multi-component MD (Construction Kit)
- MD with measuring function
- Dermal Fillers with Lidocaine
- Drug-Device combinations
3. National approach to Medical Software (SaMD)
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: 45 min.
Speaker: Regulatory Affairs Project Manager, Mikhail Vinogradov, LLM, who will discuss the key challenges and issues arising from the complex system of Medical Device registration in Russia.
Mikhail Vinogradov, LLM
Regulatory Affairs Project Manager
Other content that might interest you:
Different Affiliate Based Outsourcing Models for Regulatory Affairs
Webinar: Different Affiliate-Based Outsourcing Models for Regulatory Affairs Often questions arise about the Affiliate-Based Outsourcing (ABO) Models for Regulatory Affairs:1. How can it fit your specific needs?2. How can it adapt to your organization and setup?3....
Marketing Authorization Process in Russia
Cultural and language problems are a frequent stumbling block for multinational corporations seeking to register drugs in Russia. Additionally, the Marketing Authorization process in Russia is highly complex, and the paperwork frequently changes as the regulatory...
Drug Registration in Russia
Overview of drug registration in Russia The Russian pharmaceutical industry is expected to exceed two trillion Russian rubles in 2020, representing a roughly 10% growth over the previous year. Pharmaceutical revenues are expected to reach 2.35 trillion Russian rubles...
