This episode delves into the critical process of transferring ANMAT medical device registration in Argentina from a distributor to an independent holder. We explore the strategic risks of distributor-held registrations, such as commercial lock-in, and provide a clear overview of the transfer process, including the role of the Argentina Authorized Representative (AAR) and the importance of the governing regulation, ANMAT Provision 9688 of 2019. Listeners will learn the necessary steps and key considerations for regaining control of their market access.

Key Questions:

• Why is letting your distributor own your device registration a major risk in Argentina?

• What is an Argentina Authorized Representative (AAR) and how do they provide market flexibility?

• Which key ANMAT regulation governs the transfer of registration ownership?

• What is the most critical step for ensuring a smooth transfer from your current distributor?

• How long does the official ANMAT review process for a registration transfer take?

• What crucial clause should be included in all your distributor agreements to protect your registration?

• Can you force a distributor to transfer your registration if they refuse?

• What are the long-term commercial benefits of using an independent registration holder?

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.