In this work a regulatory value proposal is proposed that allows the production, processing, packaging, packaging, storage, spending, use, import, export, marketing and maintenance of medical devices in the country that are not regulated to date and in the same way, it makes it possible to match the existing health regulations of reference countries such as the United States. For which the processes of a) Identify regulated medical devices in the United States from the FDA database will be developed. b) Select and compare medical devices that are not regulated in Colombia from the United States databases, taking into account their level of health risk, demand for use, categorization and requirements in the country. c) Equalize the existing health regulations in the United States for three (3) medical devices that represent a greater risk to health and demand for use in the country and that to date are not regulated in Colombia.