The Amendment aims to strengthen safety controls of medical devices subject to tracking and control by obligating users of such medical devices (founders of medical institutions and doctors, oriental medicine doctors, dentists, etc., working for a medical institution) to submit records and data on the said medical devices on a monthly basis in addition to manufacturers, importers, distributors, lessors, and repairers of medical devices subject to tracking and control, who are obligated as such under the current provisions (Article 50).