Decree 4725/2005
Decree 4725/2005 (Decreto 4725/2005) is the regulation that applies to medical devices for human use in Colombia.
Colombia · Decree 4725
Colombia Decree 4725: Map the Device Requirements
Issued in two thousand five, the decree governs medical devices for human use in Colombia.
Open the video guideWhat you’ll learn
- Issued in two thousand five, the decree governs medical devices for human use in Colombia.
- Eligible class one and two A devices use automatic registration; two B and three use regular registration.
- Do not apply the decree to every health product.
Read the video transcript
Colombia’s Decree forty-seven twenty-five is more than a registration checklist. For a device team, it is a framework for how the product enters the market and stays compliant.
Issued in two thousand five, the decree governs medical devices for human use in Colombia. INVIMA administers the framework, including controls across manufacture, import, supply and post-market oversight.
Start with the product’s intended purpose, invasiveness and other relevant characteristics. Classification comes from the applicable rules, not simply the name printed on the box.
The decree uses classes one, two A, two B and three. Those classes help determine the registration route and supporting requirements, but special product categories also need attention.
Eligible class one and two A devices use automatic registration; two B and three use regular registration. Controlled-technology biomedical equipment has separate permit provisions. Check that distinction before choosing a route.
The framework also reaches the information supplied with the device. Check label details against the product dossier, and make sure records can support traceability after distribution.
Do not apply the decree to every health product. In vitro diagnostic reagents have separate rules. Also read the consolidated requirements and current INVIMA instructions alongside the original text.
A useful Colombia plan connects classification, authorization and responsibilities after launch. Our glossary explains this framework and links you to INVIMA and the official sources.
Read the full glossary at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.
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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