Medical devices
A Medical Device is any instrument, apparatus, 
implant, software, substance or other product used alone or in combination, including software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for the proper operation of the device, intended by manufacturer to be used on humans for the purposes of diagnosis, prevention, control, therapy or attenuation of a disease; diagnosis, control, therapy, mitigation or compensation of an injury or handicap; study, replacement or modification of the anatomy or of a physiological process; for intervention on conception, where a product does not exercise the main action, in or on the human body, for which it is intended, by pharmacological or immunological means or by metabolic process but whose function can be assisted by such means.
Medical Devices are considered to be:
implant, software, substance or other product used alone or in combination, including software intended by the manufacturer to be used specifically for diagnostic or therapeutic purposes and necessary for the proper operation of the device, intended by manufacturer to be used on humans for the purposes of diagnosis, prevention, control, therapy or attenuation of a disease; diagnosis, control, therapy, mitigation or compensation of an injury or handicap; study, replacement or modification of the anatomy or of a physiological process; for intervention on conception, where a product does not exercise the main action, in or on the human body, for which it is intended, by pharmacological or immunological means or by metabolic process but whose function can be assisted by such means.Medical Devices are considered to be:
- an instrument (eg. surgical instrument)
- a device (ECG, ultrasound, Rx, surgical laser, ultrasound for physiotherapy, etc.)
- an implant (dental, orthopedic prosthesis, etc.)
- a substance (eg certain types of creams, bone cements)
- etc..
