Decree 4725/2005
Decree 4725/2005 (Decreto 4725/2005) is the regulation that applies to medical devices for human use in Colombia.
Decree 4725/2005 (Decreto 4725/2005) is Colombia's principal regulation for medical devices intended for human use. It establishes lifecycle controls for safety, quality, performance, manufacture, importation, distribution, commercialization, and post-market oversight. The National Institute for Drug and Food Surveillance, INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), administers and enforces the framework.
The decree applies to domestic and foreign organizations involved in supplying medical devices in Colombia. It excludes certain categories governed by separate rules, including in vitro diagnostic reagents, which are addressed by Decree 3770/2004.
How does Decree 4725/2005 classify medical devices?
The decree uses four risk classes: Class I, Class IIa, Class IIb, and Class III. Class I represents the lowest risk and Class III the highest. Classification affects the type of sanitary authorization, evidence, review, and post-market controls that apply. Manufacturers should classify the device using its intended purpose, duration of contact, invasiveness, active characteristics, and other applicable rules rather than relying only on a product name.
What does Decree 4725/2005 require for market access?
A foreign manufacturer generally needs a Colombian authorization holder or importer to interact with INVIMA. The applicable registration pathway depends on the risk class and product characteristics. The framework also addresses labeling, storage, distribution records, technovigilance, recalls, and other post-market compliance obligations.
See the related INVIMA classification guidance and read the official text of Decree 4725/2005.
Is Decree 4725/2005 the only source for Colombian device requirements?
No. Decree 4725 is foundational, but later rules and current INVIMA procedures also govern application forms, fees, labeling, imports, changes and vigilance. Manufacturers should confirm the consolidated requirements and the authority's current filing instructions through the Colombia market guide before relying on an older checklist.
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