Turkey's New Medical Device Rule: Why Your Distributor Is Now a Liability

This episode unpacks a crucial change in Turkey's medical device regulations following its alignment with the EU MDR on June 2, 2021. We explore why foreign manufacturers can no longer use their commercial distributors as their Turkish Authorized Representative (TR-REP). The discussion focuses on the inherent conflict of interest between sales and regulatory compliance, the legal responsibilities of an independent TR-REP, and the necessary steps manufacturers must take to appoint a new representative and update their registrations in the ÜTS database to maintain market access. Key Questions: • Why is using your distributor as your Turkish Authorized Representative (TR-REP) now a significant compliance risk? • What is the fundamental conflict of interest between a distributor's commercial goals and a representative's regulatory duties? • How did Turkey's alignment with the EU MDR on June 2, 2021, fundamentally change the role of the TR-REP? • What are the specific legal responsibilities of an independent TR-REP? • What are the essential steps to transition from a distributor-rep to an independent TR-REP? • How does this regulatory shift affect your device registrations in the Turkish ÜTS database? • What are the potential consequences of failing to appoint an independent TR-REP in Turkey? • Does an independent TR-REP model improve patient safety and post-market surveillance? 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.