As Colombia's healthcare market embraces digital transformation, understanding the regulatory pathway for Software as a Medical Device (SaMD) is crucial for innovators. This episode of LATAM MedTech Insights demystifies the INVIMA registration process, revealing that SaMD is not regulated under a separate framework, but through the country's existing medical device decrees. We provide a clear, step-by-step guide for manufacturers looking to enter this promising market. We break down the essential requirements, from the critical first step of risk classification to the mandatory appointment of a local legal representative. We detail the specific documentation needed for your technical dossier, including software validation, cybersecurity measures, and the crucial Certificate of Free Sale. Learn why a simple translation of your documents isn't enough and how to avoid the common pitfalls that can lead to significant delays and rejections from INVIMA. A US-based startup with an FDA-cleared AI diagnostic tool learned this the hard way. They assumed their existing documentation would suffice for their INVIMA submission but faced a nine-month delay. The reason? Their risk analysis failed to address specific patient data privacy concerns relevant to Colombian law, and their software validation data was presented in a format that was unfamiliar to the INVIMA reviewer, leading to a cascade of questions they were unprepared to answer. This costly delay could have been avoided with localized regulatory expertise. What You'll Learn: 1. Why is there no dedicated "SaMD" regulation in Colombia, and what does that mean for your submission? 2. What is the single most important decision you'll make before starting your INVIMA application? 3. Do you need a physical office in Colombia to register your software device? 4. How crucial is a Certificate of Free Sale from your home country for the approval process? 5. What specific software validation documents does INVIMA expect to see in your technical file? 6. Beyond simple translation, what localization details are critical for your labeling and instructions for use? 7. What is the most common and costly mistake that leads to long delays in the INVIMA review process? 8. How do cybersecurity considerations play a role in the Colombian registration of SaMD? At Pure Global, we specialize in transforming these complex regulatory challenges into clear market access strategies. We offer end-to-end solutions for MedTech and IVD companies, combining local expertise in over 30 markets with advanced AI and data tools to streamline your global expansion. From initial strategy to post-market surveillance, our team acts as your local representative to ensure your innovation reaches the market efficiently. Contact us to learn more at [email protected] or visit our website at https://pureglobal.com/.