Colombia's Medical Device Classification: Navigating INVIMA's Risk Rules for Class I to III Devices

Medical Device Global Market Access · Feb 13, 2026 · 2m

This episode provides a detailed overview of Colombia's medical device risk classification system as regulated by INVIMA under Decree 4725 of 2005. We explain the four-tiered risk classes (Class I, IIa, IIb, and III), the criteria used for classification such as invasiveness and duration of use, and how a device's class determines its regulatory pathway for market approval in this key Latin American market. - What is the primary regulation governing medical device classification in Colombia? - How does INVIMA define Class I, IIa, IIb, and III medical devices? - What are the key factors used…