Medical Device Regulations in Latin America (London, United Kingdom - February 11, 2019)

  • ID: 4702055
  • Conference
  • Location: London, United Kingdom
  • 1 Day
  • Management Forum
  • Conference Dates: February 11, 2019
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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
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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

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Ana Fritschy

Ana Luisa FRITSCHY has 20 years of experience in the French Pharmaceutical Industry and Health Authorities.. She gained great knowledge and expertise in the development and registration of drugs and medical devices internationally (Latin America, Asia, Russia and CIS, and Cuba), especially in emerging countries. Currently Anna is the co-ordinator of a working group to the French Pharmaceutical Industry Association (Leem) for Brazil. She has developed expertise in this country: consultation with ANVISA authorities, transfer of marketing authorization and other aspects related to the establishment of new subsidiaries, in addition, to registrations of new products Drugs and Medical Devices in Brazil and Mexico, Argentina and Peru.

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The Cavendish Hotel
81 Jermyn Street
United Kingdom

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