Course description
Regulatory Affairs in Latin America for Medical Devices
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.
Do you work at this organisation and want to update this page?
Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.
Suitability - Who should attend?
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.
Outcome / Qualification etc.
- 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
- Explore the ANVISA GMP audit and the IMDRF scheme to eradicate this lengthy procedure
- Understand the importance of having local contacts in the region and evaluate the ‘pros’ and ‘cons’ of using distributors and host companies
Training Course Content
Session 1: Introduction to medical devices in Latin America
- Working with the national authorities in the region
- Strategies for coordinating regulatory operations in Latin America
- Overview of the competitive landscape in the region
- Mutual recognition agreements and harmonisation in the region
Session 2: Overcoming regulatory challenges in Brazil, Mexico and Argentina
- Evaluating the regulatory requirements and procedures in Brazil: FDA/EMA vs ANMAT vs COFEPRIS vs ANVISA
- Managing future changes to the regulations
- Classification of devices
- Strategic guidance on device registration, including dossier preparation:
- Dossier requirements
- Data requirements
- Timelines
- Lifecycle management including variations and renewals: managing material, design and manufacturing changes
- Interpreting labelling and packaging requirements
- PMS and Vigilance
- Reporting and follow-up responsibilities
Interactive exercise
Delegates will work through a medical device dossier for one of the countries discussed, either Brazil, Mexico or Argentina, overcoming the problems that have been addressed.
Session 3: Overcoming regulatory challenges in Brazil, Mexico and Argentina
- The GMP inspection for class II and III devices
- Why is this process so time-consuming?
- Assessing the Medical Device Single Audit Program (MDSAP) led by the IMDRF: how will it speed up the inspection process?
- Exploring how approval in the US, Canada, Japan and Korea will speed up your application in Mexico
Practical Exercise
Delegates will be taken through various case studies for Brazil, Mexico and Argentina to highlight various regulatory aspects from dossier preparation and classification to labelling and PMS.
Session 4: Overview of regulatory procedures and device registration in Colombia, Venezuela, Chile, Peru, Ecuador, Paraguay and Costa Rica
- Comparing local requirements and regulations with Brazil/Mexico/Argentina/EU/US
- Evaluating the differences in device classification
- Developing effective strategies to manage regulatory developments
- Tackling variations and renewals in the region
- Registering your device: Dossier preparation/Translation/Data requirements/Timelines
- Lifecycle management including variations and renewals: managing material, design and manufacturing changes
- Examining labelling requirements
- PMS and Vigilance
- Reporting and follow-up responsibilities
Group discussion
Delegates will be invited to share key issues and problems they have had in the various countries discussed.
Session 5: Working with local consultants, host companies and distributors in Latin America
- Examining the importance of having local contacts and how to manage those relationships
- Why use host companies and distributors?
- Assessing the advantages and disadvantages of using a host company/distributor
- Providing guidance in a challenging country
- Representing you in the country: Registration and import license holder
- What happens when this relationship breaks down?
- Methods for finding local contacts that you can trust: how do you evaluate them?
Interactive case study and group discussion
Delegates will examine various examples where the relationship between a device company and their local representative has broken down, discussing preventative measures and solutions.
Session 6: Importation requirements in Latin America
- Examining local importation requirements in the region
- Discover which countries require a permit/license and the timelines involved
- Developing success strategies for importing devices manufactured overseas using real-life case studies
Session 7: Examining specific device issues
- IVD’s
- Combination products
- Using animal derivatives
- Electronic devices
- Software
Interactive exercise
Through case studies delegates will explore issues specific to IVDs, combination products, animal derivatives and electronic devices throughout the Latin America region.
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5