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:
- Product Development
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:
Webinar: How does the conflict between UA & RU impact the pharma industry? Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And with good reason. Russia's invasion of Ukraine...
Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And, with good reason. Russia's invasion of Ukraine affects millions of people, not just in this Eastern European nation but...
Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products The webinar will highlight the practical tips and guide you through the crucial steps of marketing authorization upgrade to the Eurasian Economic Union (EAEU) one, ultimately leading you...