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.
Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.
The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.
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.
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 1st October 2018. 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.