On May 10, 2023, the Decree that amends, adds and eliminates different articles of the General Health Law (the “Decree”), was published on the Official Gazette of the Federation. The Decree includes within the term “Medical Devices” the concepts of medical equipment, prothesis, orthosis, functional supporters, diagnosis agents, dental inputs, surgical and care materials, and hygiene products.
The Decree also enables the Health Ministry (the “Ministry”) to classify as Medical Device, any input that because of its characteristics and use, can be consider as such.