With a total population of 650 million people, the medical device market in Latin America is growing and it is essential for regulatory professionals to understand the local regulations and requirements for fast market access.
Guided by trainers with a background of working for COFEPRIS, delegates will journey from country to country in the region and explore 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, Chile, Peru, Ecuador, Paraguay and Costa Rica.
Live Online Training Course
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Over 2 days students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including Q&A, break out rooms, interactive exercises, case studies, and more
- 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 two days prior to 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.