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

 

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Regulatory Submissions
  • Quality Assurance

 

Roberto F. Refeca

 

 

 

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

Roberto F. Refeca is the Associate Director, Regulatory Affairs, at Halyard Health, Inc., a medical technology company focused on advancing health and healthcare by preventing infection, eliminating pain and speeding recovery. Roberto has over 10 years of experience in Regulatory Affairs (Domestic {PMA, 510K, IDE} and International {CE-Mark Design Dossiers, Tech Files, Design Dossier Amendments, Major Applications (Class II-IV) Canada, Brazil, Mexico, Australia, China, Japan, and Clinical Trial Applications-Canada. Roberto has primary author experience/and has lead teams to successful registrations WW of Class II-Class III products including Neurovascular Stents, Combination Products (Drug Eluting Stents), Neurovascular/Peripheral/and Coronary Guidewires and Catheters, Active Implantable Medical Devices (AIMDs)/Ventricular Assist Devices (VADs), Digestive Health Products, Respiratory Health Products, Active Devices, Surgical and Infection Prevention Devices and Brazil-ANVISA GMP Inspections. Roberto has managed direct communications with the US-FDA, Health Canada, Australia-TGA, and the Costa Rica MOH, and managed/supported major company initiatives such as establishing OUS Manufacturing sites and most recently the RA lead managing the separation of Halyard Health, Inc., from Kimberly-Clark.

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

Nathalia Iensen is a pharmacist graduated in Universidade Federal do Paraná (UFPR) and post graduated in Business Administration by FIA, USP. She started her professional career in R&E as a medical devices and hygiene products scientist. Later she moved to Regulatory Affairs and Quality Assurance, leading the LATAM region requirements. Nathalia has more than 10 years of experiencing working in multinationals companies and being the LATAM representative guarantying compliance for the region.


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