Based on the medical device class qualification, we know that Class III medical devices are high-risk medical devices that require special measures for strict control and management to ensure their safety and effectiveness, such as common infusion sets, syringes, intravenous indwelling needles, cardiac stents, respiratory machines, and CTs.
Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body.