Are you planning to place medical devices on the EU market or expand into Argentina, Brazil, and Latin America?
Join our upcoming free joint webinar for a practical and strategic overview of key regulatory requirements across these regions. Industry specialists will guide you through the EU and Latin American regulatory frameworks, helping you navigate complexity, avoid common pitfalls, and accelerate your market access.
Latin America Strategy & Regulatory Landscape
Speaker: Mónica M. Guaita (MMGC), Managing Director
- Business impact of a strong regulatory strategy in Latin America
• Options for managing sanitary registrations across the region
• Country Overview: Comparison of Key Regulatory Requirements and Challenges Across key LATAM Markets
Brazil: Essential Regulatory Guidelines for Medical Device Registration
Speaker: Leticia Warcken (Vera Rosas), Senior Regulatory Affairs Specialist
Brazil is one of the fastest-growing medical device markets globally, offering major opportunities—but also regulatory complexity.
- Main regulatory pathways for device registration in Brazil
• Key challenges in the Brazilian regulatory landscape: timelines, documentation, and compliance
• ANVISA’s latest initiatives to optimize review timelines and improve regulatory efficiency.
EU Market Access under MDR (EU) 2017/745
Speaker: Fran Rodríguez (Asphalion), Medical Device Manager
• Key requirements for placing medical devices on the EU market under MDR
• EUDAMED and current EU regulatory expectations
• Post-market obligations and common compliance challenges for manufacturers entering or operating in the EU.
Why attend?
Gain practical insights, avoid common pitfalls, and build a solid regulatory strategy to successfully enter and operate in highly regulated markets.
When? May 14 – 15:00 (CEST)/ 10:00 (UTC -3)
Save your spot now! https://bit.ly/48Jc1mw
Contact us for further information: [email protected]
