What are medical devices?
A medical device is any instrument, apparatus or appliance that is used to diagnose, monitor or treat a disease, injury or handicap in humans. The term “medical device” applies to a broad range of products, devices and equipment, from simple tongue depressors and bedpans to laser surgical devices. Medical devices can also include certain electronic radiation emitting devices with medical applications, including ultrasound devices and x-ray machines.
While the term is broadly applied, medical devices should not be confused with other classes of products used to treat medical conditions. For example, medications and pharmaceutical preparations, which treat medical conditions through chemical action or by being metabolised by the body, are not considered medical devices, and are subject to different regulations and requirements.