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 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 first established in the early 1990s, though it has since been restructured to expand its regulatory oversight capabilities.

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
Address: Carrera 10#64 - 28 Bogotá, Colombia‍
Phone: (+57)(601) 242 50 00