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 aging 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 delegates 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.
Ruslan Kalachev is Development Director in BeAWire Regulatory Affairs Agency which specializes in medical device and IVD product registration in Russia.
Previously, he worked as an engineer and sales person in medical device companies, which gave him an understanding of the government purchasing system in Russia.
Following this, Ruslan joined the regulatory affairs industry. His mission in the company is to provide guidance to manufacturers worldwide with regards to regulatory expected changes.
Alongside this, he regularly gives guidance to professionals in the industry through speaking at events globally.
Tatiana Nosova is CEO in BeAWire Regulatory Affairs Agency which is highly specialized on medical device and IVD product registration in Russia.
Tatiana studied engineering science at the Biomedical Engineering Faculty, The Bauman Moscow State Technical University. After graduating, she worked in Russian medical devices manufacturing company as a product registration specialist, which gave her a thorough understanding of the requirements of a national manufacturing company.
Tatiana was the head of medical device registration departments in 2 different companies and several manufacturing teams have successfully registered their products under her guidance.
BeAWire consultancy has worked for more than 10 years in approval services in Belarus, Kazakhstan, Kyrgystan, Russia and Ukraine. During this time their specialists successfully finished state registration for different product types: from X-Rays to liquid implants and received more than 150 registration certificates in total. Their services also include assistance with testing (safety and biocompatibility), standards, approvals and assistance with clinical trials. They have also exhibited and delivered seminars globally on Russian and EAEU regulations.
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.
MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.
Once you have registered and made the full payment, you will be given login details to access the course.
This online academy course can be accessed from 4 March 2019 1 module will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.
Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.