Medical Device Definition
Medical Devices are health products that have a physical or mechanical effect when used on human bodies. These devices are used to:
- Diagnose, alleviate or treat a medical condition, e.g., X-ray machines, contact lenses, prosthetic knee implants.
- Measure or monitor functions of the body, e.g., blood pressure or blood sugar monitoring machines.
Products used to maintain or support general well-being without specific medical claims, such as body toning equipment, magnetic accessories and massagers, are not medical devices.
Medical Device Classification System
International Classification |
Risk Level |
Examples |
Class A |
Low risk |
Wheelchairs or tongue depressors |
Class B |
Low to Moderate Risk |
Hypodermic needles or suction equipment |
Class C |
Moderate to High Risk |
Ventilators or bone fixation plates |
Class D |
High risk |
Heart valves or implantable defibrillators |