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 and was established in the early 1990s and serves as Colombia’s cornerstone for national health regulation.  

INVIMA ensures that medical devices entering the Colombian market meet rigorous standards of safety, quality, and efficacy in accordance with Decree 4725/2005, the primary medical device regulation in Colombia. In vitro diagnostic devices (IVDs) are regulated by INVIMA according to Decree 3770/2004. 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.

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