Switzerland's CH-REP Rule: Is Your Distributor a Compliance Risk?

This episode delves into the critical role of the Swiss Authorized Representative (CH-REP) for medical device manufacturers. We explore the significant regulatory changes that made the CH-REP mandatory and uncover the hidden risks of appointing a commercial distributor for this function. Learn why an independent CH-REP is the more strategic choice for ensuring long-term compliance and commercial flexibility in the Swiss market. • Why did Switzerland become a regulatory "third country" for medical devices on May 26, 2021? • What are the core duties and legal liabilities of a Swiss Authorized Representative (CH-REP)? • What is the fundamental conflict of interest when your distributor is also your CH-REP? • How does tying regulatory compliance to a sales partner limit your commercial freedom? • Is your distributor truly equipped to handle joint liability for your devices? • What makes an independent CH-REP a more robust and flexible long-term solution? • What is involved in the process of switching from a distributor to an independent CH-REP? • Are there still grace periods for appointing a Swiss representative? 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.