With the medical device markets in Latin America estimated to be worth $11 billion and growing, it is essential for regulatory professionals to understand the local regulations and requirements for fast market access. Journeying from country to country in the region, this course explores the key issues in Latin America from dossier preparation and classification to lifecycle management and labelling so you have the required skills to get your device approved.
As well as learning about the fundamentals of local regulations the course will also develop best practiced strategies to manage important relationships and import your devices, which can cause significant problems if overlooked.
Main focus: Brazil, Mexico and Argentina
Also discussed: Colombia, Venezuela, Chile, Peru, Ecuador, Paraguay and Costa Rica
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Over 2 days students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact firstname.lastname@example.org.
What will you learn?
Existing mutual recognition agreements
Discover mutual recognition agreements and harmonisation in the region for a simplified approval process in multiple countries
Guidance on dossier requirements and structure to avoid rejections and gain faster approval of devices
Learn about future regulatory developments in the region
Examine lifecycle management, such as variation and renewal procedures to effectively manage your device post approval
ANVISA GMP audits
Explore the ANVISA GMP audit and the IMDRF scheme to eradicate this lengthy procedure
Forming local partnerships
Understand the importance of having local contacts in the region and evaluate the ‘pros’ and ‘cons’ of using distributors and host companies
Who is this course for?
This course has been designed for experienced regulatory professionals who are either new to operations in Latin America or are already working in the region and want to further increase their knowledge.
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.
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others
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