Local Reps, Global Reach: The Unseen Gatekeepers of MedTech Access

Medical Device Global Market Access · Sep 26, 2025 · 3m

This episode explores the critical, often mandatory, role of in-country representatives for medical device manufacturers entering foreign markets. We cover their functions from initial product registration and labeling to post-market vigilance and adverse event reporting. The episode also highlights the strategic pitfalls of using a distributor as a representative and the benefits of appointing an independent professional to maintain control and flexibility. • What is an in-country representative and why is it mandatory in most markets? • How does a local representative facilitate the product…