Colombia Decree 4725: Map the Device Requirements

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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.