Equipment refers to instruments, devices, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly on the human body, including the required computer software.

Equipment and medical supplies are included.

The efficacy is primarily obtained through physical means, not through pharmacological, immunological, or metabolic pathways, or even if these pathways are involved, they only play a supplementary role.

The purpose is for disease diagnosis, prevention, monitoring, and relief; injury diagnosis, monitoring, relief, or functional compensation; examination, substitution, regulation, or support of physiological structures or processes; life support or maintenance; pregnancy control; and providing information for diagnostic purposes by examining samples from the human body.