Medical Device Regulations in Russia - Online Academy
The Russian medical device industry is one of the largest markets in the world. Many companies are enticed by the large potential for growth, a healthcare system that favours medical devices from foreign manufacturers and an ageing population.
The processes that the Russian medical device agency Roszdravnadzor (RZN) has in place are often poorly understood by companies outside of the region and it is not uncommon that product registrations are rejected. Furthermore, even with products on the market, medtech companies have to comply with several federal laws and regulations from various government bodies.
This course will provide participants with the knowledge to remain compliant with Russia's medical device regulations throughout the process of registering medical devices and maintaining them through the product lifecycle.
Suitability - Who should attend?
This course would be useful for people within regulatory affairs departments who have local representations in this market and want to know more about the country. It will provide them with a broad overview of what the changes will be.
Outcome / Qualification etc.
- Learn about the Russian healthcare industry and opportunities that are arising for medical device companies
- Understand key regulatory requirements for successful submissions
- Examine key post-registration maintenance procedures to ensure compliance
- Discover industry insights as to why registrations and post submission changes fail
- Discover the complex procedures for post market surveillance
Training Course Content
- Module 1: General information about the market
- Module 2: Medical device and IVD product registration in Russia - current procedures
- Module 3: Duplicates and amendments of/in existing registration certificates
- Module 4: Single market of medical devices and IVD products within EEU (ARM, BEL, KAZ, KGZ, RUS)
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PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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