This course introduces the laws and regulations on medical device management, including key provisions, classification and grading of medical devices, documents required for medical device registration, tests to be performed, procedures, and the points for attention. In addition to lecture, students will also be asked to write the application forms for medical device registration in groups as PBL teaching method. Let students consider the process of company establishment or document delivery. This will make students more familiar with the application process through pratical participation.