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Medical Device Regulations in Latin America Training Course

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 include Brazil, Mexico, Colombia and Peru.

Course overview

The Latin American market for medical devices has seen significant expansion in recent years and this intensive one-day seminar will provide an essential insight into key areas, ensuring that delegates take full advantage of the opportunities available. The regulatory routes of approval will be covered for each country and regulatory strategies will be discussed to achieve successful approval. Participants will also get the opportunity to learn about the culture of each country and gain a better understanding of how the national authorities function.

The programme will include interactive sessions to enable participants to share experiences and discuss the complexities of the subject with a medical device professional who has direct experience of working in this geographic region.

This event will be fundamental to anyone looking to access the LATAM medical device market.

Who should attend?

This seminar will be of particular interest to:

  • Regulatory personnel involved in the regulation for medical devices in LATAM
  • Those who are new to working with medical devices in the region
  • Medical device professionals interested in an update on recent developments
  • Regulatory affairs managers
  • Business development managers


Introduction to medical devices in the LATAM region

  • Competitive landscape overview and market opportunities
  • Working with the national authorities
  • How to coordinate 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
  • Institut Straumann AG
  • 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
  • Stryker/HeartSine
  • Synthes GmbH
  • Systagenix Wound Management
  • Ypsomed AG