Decree 3770/2004

Decree 3770/2004 (Decreto 3770/2004) is the core regulation on in vitro diagnostic (IVD) devices in Colombia. It was issued in 2004 to establish a regulatory framework to ensure the safety, quality, and reliability of IVD products used in laboratories and healthcare settings. It is the companion regulation to Decree 4725/2005 on medical devices. The decree is enforced by the National Institute for Drug and Food Surveillance, INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), which evaluates compliance and conducts post-market monitoring.

Decree 3770/2004 introduced a risk-based classification system for IVDs (Classes I, II, and III), which escalates the level of regulatory scrutiny in line with a product's risk to public health. Low-risk Class I reagents follow a simpler registration route, while higher-risk Class II and III reagents require more stringent evidence of performance and safety, as well as full sanitary registration. The decree also addresses responsibilities for manufacturers, importers, and distributors to maintain proper storage, handling, and vigilance systems. Subsequent updates, such as Decree 581 of 2017, have refined specific provisions, particularly for Class III IVDs.

Read Decree 3770/2004 here.

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