In this episode of LATAM MedTech Insights, we explore the non-negotiable Spanish labeling requirements for medical devices in Colombia. We delve into INVIMA's regulations under Decree 4725 and explain why simply having FDA or CE approval isn't enough to guarantee a smooth market entry. We’ll walk through a real-world case study of a US company whose launch was delayed by six months due to overlooked translation of their device's software and manual. This costly mistake highlights the critical importance of a localized approach and the severe commercial impact of non-compliance. Learn what "labeling" truly covers and how to avoid common pitfalls. Key Questions Answered in This Episode: - What specific Colombian decree mandates Spanish for medical device labels? - Does "labeling" include just the box, or also the software and user manual? - Can I use a simple sticker with Spanish translation over my original English label? - What are the real business costs of getting the language requirement wrong in Colombia? - Why is a direct machine translation of my IFU a high-risk strategy? - How early in my product development should I plan for multi-language labeling? - What's the best practice for designing packaging for both US and Colombian markets? At Pure Global, we specialize in navigating these complex regulatory landscapes. We provide end-to-end solutions, from local representation to AI-powered technical dossier preparation, ensuring your MedTech and IVD products meet all local requirements in over 30 countries. Don't let language be a barrier to your success. Contact us for a consultation at [email protected] or visit https://pureglobal.com/.