Decree 4725/2005

What is Decree 4725/2005? Decree 4725/2005 (Decreto 4725/2005) is the regulation that applies to medical devices for human use in Colombia. The decree establishes a comprehensive regulatory structure to ensure the safety, quality, and proper functioning of medical devices across their entire lifecycle, from production and importation to commercialization and maintenance. The decree applies to domestic and foreign entities engaged in the sale and distribution of medical devices, though it excludes custom-made devices and in vitro diagnostic reagents. The Ministry of Health and Social Protection enacted the decree in 2005; National Institute for Drug and Food Surveillance, known as INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), enforces the decree through its oversight of medical device safety. Decree 4725/2005 lays out key definitions to provide regulatory clarity and enforcement. It also defines 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 for a specific device. The decree also addresses quality and risk management by mandating that institutions comply with BPM and maintain appropriate storage, vigilance, and surveillance systems to mitigate risks associated with device use.