Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access. cover art

Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.

Pure Global's Guide to ANMAT: Why Your Choice of Medical Device Registration Holder in Argentina Can Make or Break Your LATAM Market Access.

Listen for free

View show details

About this listen

 In this episode of LATAM MedTech Insights, we dive into one of the most critical and often misunderstood aspects of entering the Argentine medical device market: the role of the local registration holder. While ANMAT's requirement for a local representative seems straightforward, the legal implications of who you choose can have massive consequences for your business. We explore why appointing your commercial distributor as your registration holder can be a high-risk strategy. This episode uncovers how this common practice can lead to a complete loss of market access, forcing companies to restart the costly and time-consuming registration process from zero. We detail the strategic advantages of separating your regulatory representation from your commercial partnerships to ensure business continuity and protect your investment. **What You'll Learn:** - Why is ANMAT's requirement for a local registration holder more than just an administrative step? - What are the hidden risks of appointing your distributor as your registration holder in Argentina? - Who legally owns your medical device registration in Argentina, and why does it matter? - If you split with your local partner, what happens to your hard-won market approval? - How can an independent representative provide business continuity and control over your assets? - Is this registration ownership model unique to Argentina, or is it a common theme in LATAM? - What key criteria should you use when selecting a local registration holder in Argentina? At Pure Global, we specialize in providing independent, expert local representation to safeguard your market access. We act as your registration holder across Latin America, ensuring you maintain full control over your assets while having the flexibility to build the best commercial strategy. Ready to secure and streamline your entry into Argentina? Contact us at info@pureglobal.com or visit https://pureglobal.com/ for a strategic consultation.
No reviews yet
In the spirit of reconciliation, Audible acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.