Surgical simulation training device is not a medical device

Medical device means an instrument, equipment, appliance, material or other article, including the required software, used alone or in combination on the human body; its use on the human body surface and in vivo is not obtained by pharmacological, immunological or metabolic means, but there may be participation in these means and play a certain supporting role; its use is intended to achieve the following intended purposes: (a) prevention, diagnosis, treatment, monitoring, alleviation of disease; (b) diagnosis, treatment, monitoring, alleviation of injury or disability, compensation; (c) research, replacement, regulation of anatomical or physiological processes; (d) diagnosis, treatment, monitoring, alleviation, compensation of anatomical or physiological processes, treatment, guardianship, and mitigation of disease; (ii) diagnosis, treatment, guardianship, mitigation, and compensation for injury or disability; (iii) study, substitution, and regulation of anatomical or physiological processes; and (iv) pregnancy control. Therefore, this is not a medical device.