Maintain compliance with the medical device regulations in Russia throughout the entire product life-cycle
Course Overview
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 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 Academies
MDTI online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.
Over 4 weeks students will learn through:
- 4 modules, split up into multiple bitesize recorded videos
- Quizzes to test your knowledge
- Revisiting the content with unlimited access to all the materials for 3 months
- Participating in the discussion forum to interact with other students
- Interacting with the trainer through the forum during the course
- Additional content such as materials and white papers available to download
Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.
What will you learn?
Industry insight
Industry insight
Learn about the Russian healthcare industry and opportunities that are arising for medical device companies
Regulations
Regulations
Understand key regulatory requirements for successful submissions
Post-registration actions
Post-registration actions
Examine key post-registration maintenance procedures to ensure compliance
Common mistakes to avoid
Common mistakes to avoid
Discover industry insights as to why registrations and post submission changes fail
Post-market surveillance
Post-market surveillance
Discover the complex procedures for post-market surveillance
Who is this course for?
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.
Find out more about online academies...
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.
On average, delegates of our online academies said...
4/5
85%
4/5
CPD Certified
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
25% discount on Routledge books
As a student on the course you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge website www.routledge.com.
Examples of books and eBooks within medical devices include:
- Medical Device Quality Assurance and Regulatory Compliance
- Medical Instruments and Devices: Principles and Practices
- Design Controls for the Medical Device Industry, Third Edition
- Medical Device Regulatory Practices: An International Perspective
- Handbook of Medical Device Regulatory Affairs in Asia: Second Edition
- And more
