This episode explores the evolving global market entry strategies for medical devices. We discuss the significant regulatory hurdles in the EU due to MDR/IVDR, leading manufacturers to increasingly prioritize the U.S. market. We also delve into the burgeoning opportunities in high-growth emerging markets across Asia-Pacific and Latin America, offering insights into strategic planning for today's complex MedTech landscape.

Key Questions:

• Why is the EU becoming a less attractive first-launch market for medical devices?

• What makes the U.S. market increasingly appealing for MedTech manufacturers?

• How are new EU regulations (MDR/IVDR) impacting device approval timelines and costs?

• Which Asia-Pacific countries offer the most promising growth for medical devices by 2025?

• What are the key drivers behind Latin America's expanding medical device market, projected to reach $71 billion by 2032?

• How should manufacturers adapt their regulatory strategies in this shifting global environment?

• What role do local partnerships play in accessing emerging markets?

• Are there benefits to pursuing simultaneous submissions in multiple regions?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.