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Medical Device Registration in Russia. The Essentials

Successful Medical Device Registration in Russia The Essentials

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:

  1. Russian Competent Authorities in the medical device field
  2. State Legislation and levels of legislation
  3. The scheme of State registration
  4. The registration dossier and list of the documents
  5. Testing and evaluation (technical, toxicological, clinical)
  6. Post-registration activity
  7. 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.

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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

Mikhail Vinogradov, LLM

Regulatory Affairs Project Manager

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