Instruments refer to devices, equipment, implements, in vitro diagnostic reagents and calibrators, materials, and other similar or related articles used directly or indirectly on humans, including the required computer software.

Equipment and medical consumables are included.

The efficacy is primarily obtained through physical means, not via pharmacology, immunology, or metabolism, or although these methods may be involved, they only serve as auxiliary.

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