Medical Device Registration in Russia. Challenges and Issues

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)