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.
Decree 3770/2004 (Decreto 3770/2004) is Colombia's core regulation for in vitro diagnostic (IVD) reagents. It establishes controls intended to support the safety, quality, and performance of IVD products used in laboratories and healthcare settings. The decree complements Decree 4725/2005, which covers non-IVD medical devices.
The National Institute for Drug and Food Surveillance, INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), administers the framework, reviews sanitary-registration applications, and conducts post-market oversight.
How does Decree 3770/2004 classify IVDs?
The decree uses Categories I, II, and III, with regulatory scrutiny increasing according to the risk presented to individual and public health. Classification drives the registration route and the level of technical, quality, and performance evidence expected. Applicants should apply the legal classification rules to the intended use and test characteristics rather than infer the class from a product name.
What does the decree require?
The framework addresses sanitary registration, labeling, importation, storage, distribution, quality controls, and post-market responsibilities. Manufacturers and their Colombian authorization holders should maintain evidence supporting analytical and clinical performance, appropriate handling, traceability, and vigilance systems. Later measures, including Decree 581 of 2017, amended specific provisions, so applicants should review the consolidated legal framework before filing.
See our Colombia IVD classification guidance and registration overview. Read the official text of Decree 3770/2004.
Is Decree 3770/2004 still the only rule for Colombian IVDs?
No. The decree remains a foundational part of the framework, but applicants must also follow current implementing resolutions, INVIMA procedures and later requirements that apply to registration, labeling, importation and post-market control. The operational filing strategy should therefore be checked against current Colombia market requirements, not built from the decree alone.
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