In this webinar, Regulatory Affairs Project Manager, Mikhail Vinogradov, LLM, discusses the challenges and issues arising from the complex system of Medical Device registration in the Russian Federation.
Some particular cases are reviewed:
- The specificity of national classification of medical devices: why some medical products are medical devices in the EU but not considered as medical devices in Russia
- Issues with the registration of complex and multi-component medical devices
- National approach to Medical Software (SaMD).
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.
The following topics are discussed:
1. Classification problem - Medical Device or not Medical Device?
2. Registration of Complex Medical Devices:
- Complex IVD Systems
- Multi-component MD (Construction Kit)
- MD with measuring function
- Dermal Fillers with Lidocaine
- Drug-Device combinations
3. Medical Software - SaMD, Neuronal Networks for medicine
Who Should Attend?
Professionals from medical device companies working within:
• Regulatory
• R&D
• QA/QC
• Compliance
• Product Development
• Manufacturing
16 сен 2024
