Medical Devices Act Article 15

Medical device manufacturers and dealers engaging in the import or repair shall employ qualified technicians according to the categories of medical devices.Regulations governing the categories of medical devices, qualifications and proportions of technicians, the number of hours in education and training courses referred to in the preceding paragraph, and other related matters shall be established by the central competent authority.If qualified technicians employed by medical device manufacturers and dealers engaging in the import or repair as specified in the first paragraph cannot perform their tasks due to dismissal, resignation, or other reasons and replacements are not employed separately, the competent authority shall order the medical device manufacturers and dealers to make corrections within a time period. Those who fail to make corrections within the time period shall immediately cease the manufacture, import, or repair of medical devices.