Navigating INVIMA: Colombian Rules for Medical Device Labeling, IFU, and Spanish Translation

Medical Device Global Market Access · Feb 19, 2026 · 2m

This episode provides a detailed overview of the regulatory requirements for medical device labeling, Instructions for Use (IFU), and Spanish translation for market entry into Colombia. We explore the specific rules set by the national authority, INVIMA, and explain how these elements are meticulously evaluated during the registration process to ensure patient safety and device efficacy. - What is INVIMA's primary language requirement for medical device labels in Colombia? - Which Colombian decree governs the rules for labeling and IFUs? - How does an inaccurate Spanish translation affect the…