INVIMA: Your Colombia Device Roadmap

Read the video transcript

Planning to sell a medical device in Colombia? INVIMA is a name you will hear early. But knowing the regulator is only the first step.

INVIMA is Colombia’s national health-product regulator. For medical devices, its work covers market authorization, inspections and oversight after products reach patients.

Start with the actual product: its intended purpose, how it works and who will use it. Those details shape the classification and the evidence you need.

Colombia uses four device risk classes: one, two A, two B and three. The classification affects the registration route; a familiar product name alone is not enough.

For eligible devices outside controlled technology, classes one and two A use automatic registration. Classes two B and three follow regular review. Automatic still means meeting the requirements.

Before filing, check that the device description, label and supporting documents agree. A mismatch between the product and the paperwork can create avoidable questions.

For an overseas manufacturer, clarify the Colombian holder and importer arrangements early. Also decide who will maintain records, manage changes and handle safety communications after launch.

Use current INVIMA instructions alongside the applicable rules. Our glossary links the regulator, Colombia’s device framework and the next practical steps in one place.

Read the full glossary at Pure Global. One partner for medical device registration and regulatory support across more than thirty markets.