The Regulations on the Supervision and Administration of Medical Devices stipulates that medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related items, including the required computer software, which are directly or indirectly used in human body; Its effectiveness is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although these means are involved, they only play an auxiliary role; Its purpose is:
(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Examination, substitution, adjustment or support of physiological structure or process;
(4) supporting or maintaining life;
(5) Pregnancy control;
(6) provide information for medical or diagnostic purposes by examining human samples.