ABSTRACT
Medical devices are essential tools of health care. According to Health Canada, the term ‘medical device’ covers a ‘wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition’ (Medical Devices, Health Canada 2006). In Canada, ‘medical devices’ are only for human use (Medical Devices Regulations, Government of Canada 2006). This is in contrast with the definition of ‘medical devices’ given by the Food and Drug Administration of the United States of America, whereby such devices are ‘intended to affect the structure or any function of the body of man or other animals’ (US Food and Drug Administration 2006).
