INVIMA (National Institute for Drug and Food Surveillance)
The National Institute for Drug and Food Surveillance, known as INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), is Colombia’s primary regulatory authority overseeing the safety, efficacy, and quality of health‑related products.
Colombia · INVIMA
INVIMA: Your Colombia Device Roadmap
INVIMA is Colombia’s national health-product regulator.
Open the video guideWhat you’ll learn
- INVIMA is Colombia’s national health-product regulator.
- For eligible devices outside controlled technology, classes one and two A use automatic registration.
- For an overseas manufacturer, clarify the Colombian holder and importer arrangements early.
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.
The National Institute for Drug and Food Surveillance, known as INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), is Colombia’s primary regulator of health‑related products. Its jurisdiction includes medical devices, in vitro diagnostics (IVDs), pharmaceutical drugs, biological products, cosmetics, dietary supplements, and food items. INVIMA operates under the Ministry of Health and Social Protection. INVIMA ensures that medical devices entering the Colombian market meet rigorous standards of safety, quality, and efficacy. INVIMA evaluates technical documentation according to their risk classification and grants device registrations on approval. INVIMA also enforces post-market surveillance and monitors adverse events and recalls to ensure compliance throughout the device life cycle.
When was INVIMA established?
INVIMA was created by Article 245 of Law 100 of 1993. Its structure was defined in 1994, and the institute began operations on 1 February 1995. Its current organization and functions reflect later restructuring, including Decree 2078 of 2012.
What are the key medical device regulations enforced by INVIMA?
INVIMA enforces Decree 4725/2005, the primary medical device regulation, and Decree 3770/2004, which dictates regulatory requirements for in vitro diagnostic devices (IVDs).
Does INVIMA charge fees for medical device registration?
Yes, INVIMA charges mandatory government fees for medical device registrations, renewals, and modifications. Fees vary based on risk classification, though registering multiple devices can lower the per-device cost of registration.
How can I contact INVIMA?
INVIMA can be contacted Monday through Friday, 7:30 am to 3:30 pm, via their switchboard at (+57) (601) 242 50 00. Their toll-free line is available within Colombia at 018000 122220.
Website: INVIMA and its official medical device directorate overview
Address: Carrera 10#64 - 28 Bogotá, Colombia
Phone: (+57)(601) 242 50 00
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