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Regulatory Affairs in Latin America for Medical Devices

Next dates: 13-14 Dec 2017; Bookings open for 25-26 Apr 2018

Radisson Blu Edwardian Grafton, London

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 intense 2-day 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

  • 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

Virginie Rivas has over 15 years’ experience within quality, regulatory affairs and clinical for various international pharmaceutical groups. She has successfully registered various pharmaceutical products such as vaccines, drugs, medical devices of all classes, cosmetics and dietary supplements in more than 80 countries but with significant expertise acquired and recognised in Latin America.

 

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.

Medical devices software development and applications

Over c.30 minutes, this webinar explores a major area of development from the last decade. Presented by Richard Young, it covers:

- The changing regulatory environment for medical devices in Europe 
- FDA regulation 
- Key considerations in development environments 
- Key standards 

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