INSIGHT INTO MEDICAL DEVICE REGISTRATIONS IN LATIN AMERICA: BRAZIL & MEXICO

Brazil and Mexico are the two largest markets for medical devices in Latin America, which continue to flourish as many government bodies within the region are working to simplify the process for international manufacturers looking to market in the area. The regulatory environment in Latin America has undergone drastic changes over the past decade with initiatives towards greater harmonization such as the adoption of ICH guidelines and enhanced regulatory review transparency and accountability. Obtaining device registration in Brazil and Mexico can be a stringent process and manufacturers must fully comprehend and apply the appropriate ANVISA and COFEPRIS guidelines to ensure success.

• Market entry and regulatory strategy development
  • Registration review time frames
  • Common dossier requirements
• Brazil: BGMP inspections and MDSAP Audits
• Mexico: Equivalence Process and 3rd Party Review

Speakers:
Roberto F. Refeca
Associate Director, Regulatory Affairs
Halyard Health, Inc

Nathalia Iensen
Regulatory Affairs & Quality Assurance Manager for Latin America
Halyard Health, Inc