Decree 4725/2005

Decree 4725/2005 (Decreto 4725/2005) is the regulation on medical devices for human use in Colombia enacted in 2005. The decree establishes a comprehensive regulatory structure to ensure the safety, quality, and proper functioning of medical devices across their life cycle. It applies to domestic and foreign entities engaged in the sale and distribution of medical devices Colombia, though it excludes custom-made devices and in vitro diagnostic reagents (which are covered by Decree 3770/2004). The National Institute for Drug and Food Surveillance, known as INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), enforces the decree.

Decree 4725/2005 outlines a risk-based classification scheme (Classes I to III) that aligns with international norms to determine the level of oversight and type of market authorization pathway required to register a specific device in Colombia. The decree also addresses quality and risk management by mandating that institutions maintain appropriate storage, vigilance, and post-market surveillance systems.

Read Decree 4725/2005 here.