This episode explores the strategies and regulatory hurdles involved in bringing medical devices to underserved and emerging global markets. We discuss how to leverage existing approvals, the critical role of local representation, and the use of technology to streamline multi-country submissions, focusing on promising regions like Latin America and Southeast Asia.

Key Questions:

- How can you leverage your existing US or EU approvals to enter new regions?

- What are the primary regulatory hurdles in Latin American and Southeast Asian markets?

- Why is local representation critical for success in underserved economies?

- How can technology streamline submissions for multiple, non-harmonized markets?

- What is the first step in identifying the most promising underserved markets for your device?

- Is it possible to use a single registration process to access dozens of countries?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, streamlining global market access with a unique blend of local expertise and advanced AI. We help you develop efficient regulatory strategies, act as your local representative in over 30 markets, and use AI to compile technical dossiers for faster submissions. Our integrated approach allows a single registration process to unlock multiple international markets simultaneously. To accelerate your global expansion and access our FREE AI tools and regulatory database, visit us at https://pureglobal.ai or contact our team at [email protected].