Episode Details

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 registration process? • What are their legal responsibilities for post-market surveillance and vigilance? • Why could appointing your distributor as your representative be a costly mistake? • How does an independent representative give you more control over your business? • What information must be included on the product labeling regarding the representative? • Who do national authorities contact if there is a safety issue with your device? • How can you switch distributors without having to re-register your product? 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 info@pureglobal.com for tailored support.