MEDICAL DEVICE of Medical device. Although it is universal in character, and the definition will fit that of many but every country in the world, I will put what Chilean law says: Any instrument, apparatus, application, material or article, including software, used alone or in combination and defined by the manufacturer to be used directly on humans, provided that its main planned action on the human body is not achieved by pharmacological means , immunological or metabolic, although such means may be available to their function; for the purpose of diagnosing, preventing, monitoring or relieving a disease, damage or disability; replacement or modification of the anatomy of a physiological or conception regulation process.