In this episode of LATAM MedTech Insights, we demystify the seemingly simple but highly nuanced process of renewing medical device registrations in Argentina. We take a close look at the specific requirements outlined in ANMAT's Disposition 2318/2002, focusing on the critical 90-day submission deadline and the legally binding "sworn declaration." We explore the common pitfalls that can lead to costly delays and even market withdrawal. A minor change in your product's documentation or manufacturing process, considered insignificant in other markets like the EU or USA, could completely invalidate your renewal application in Argentina, forcing you into a lengthy and expensive new registration process. **What You'll Learn:** - What is the absolute deadline for submitting your renewal application to ANMAT, and what are the consequences of missing it? - How does ANMAT's definition of a "significant change" differ from that of the FDA or European Notified Bodies? - Why could a simple update to your Instructions for Use (IFU) derail your entire renewal? - What specific information is included in the "sworn declaration," and what are the legal risks involved? - When is a renewal not an option, forcing you to file for a completely new registration? - What is the critical role of the Authorized Local Representative (ARL) in ensuring a smooth renewal process? Struggling to keep up with the diverse and evolving regulatory requirements across Latin America? At Pure Global, we offer end-to-end regulatory consulting solutions for MedTech and IVD companies. We combine local expertise with advanced AI and data tools to streamline global market access, acting as your local representative in over 30 markets, including Argentina. Let us help you ensure your products remain compliant and accessible. Contact us today at [email protected] or visit https://pureglobal.com/ for a consultation.