Medical Device Regulations in Latin America

This seminar will provide an essential overview of the key areas of requirements for approvals for Medical Devices in Latin America. Countries to be covered: Brazil, Mexico, Colombia and Peru

Course overview

This new seminar will provide an essential overview of the key areas of requirements for approvals for medical devices in Latin America.
Focusing on the regulatory requirements and developments in individual countries, the course will include interactive discussion to allow you
to exchange experiences with other colleagues.

Benefits of attending:

  • Understand medical device regulations in LATAM countries
  • Learn the definition of Medical device and their classification
  • Gain knowledge of the registration procedures
  • Discuss recent developments in the region LATAM
  • Opportunities to meet, network and share experience with other industry collegues

Who should attend?

This Seminar will be of particular interest to:

  • Anyone involved in the regulation for medical devices in LATAM
  • Those who are new to working with medical devices in the region
  • Anyone interested in an update on recent developments


Introduction to medical devices in the LATAM region

  • Competitive landscape overview and market opportunities
  • Working with the national authorities
  • How to co-ordinate regulatory operations in the region
  • Mutual recognition and harmonisation
  • Local importation requirements
  • Which countries require permits/licences
  • Working with local consultants and distributors


  • Overview of medical device legislation in Brazil
  • ANVISA regulatory approval process
  • Overview of the IVD regulatory requirements in Brazil
  • Medical Device Single Audit Programme (MDSAP)


  • Understand the requirements of COFEPRIS regulation for medical devices
  • Medical device classifications
  • COFEPRIS registration routes
  • Post-submission requirements
  • Exploring strategies for bringing a medical device product to market in Mexico

Colombia and Peru

  • Legal overview of medical device regulations in these countries
  • Medical device classifications
  • Registration dossier requirements
  • Renewal and variations
  • Regulatory strategies to access these markets

Discussion sessions will take place throughout the day

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

Previous customers include...

  • Alifax SPA
  • Arjo Ltd Med AB
  • Biosensors Europe SA
  • Clinica
  • Coloplast A/S
  • Cook Ireland Ltd
  • Diasorin S.p.A
  • Elekta Oncology Systems Ltd
  • Espicom Business Intelligence
  • Finsbury Instruments Ltd
  • Gyrus Medical Ltd (Cyrus ACMI)
  • Henkel Ireland Limited
  • Kimberly-Clark Europe Ltd
  • Medtron AG
  • Novartis Consumer Health SA
  • Omega Teknika
  • Ortho-Clinical Diagnostics
  • Q-Med AB
  • Reckitt Benckiser
  • Richard Wolf GmbH
  • Roger Neville IT Ltd
  • Sanofi Winthrop Industrie
  • Smiths Medical International Ltd
  • Sorin Biomedica Cardio Srl
  • Synthes GmbH
  • Systagenix Wound Management
  • Ypsomed AG