What is a medical device?
'Medical device' means any instrument, apparatus, implement, machine, appliance,
implant, in vitro reagent or calibrator, software, material or other similar or
related article:
a) Intended by the manufacturer to be used, alone or in combination, for human beings
for one or more of the specific purpose(s) of:
◊ diagnosis,
prevention, monitoring, treatment or alleviation of disease
◊ diagnosis,
monitoring, treatment, alleviation of, or compensation for, an injury
◊ investigation,
replacement, modification, or support of the anatomy of a physiological process
◊ supporting
or sustaining life
◊ control of conception
◊ disinfection
of medical devices
◊ providing
information for medical or diagnostic purposes by means of in vitro examination
of specimens derived from the human body
◊ aids for
disabled/handicapped people
◊ Prescription
eye glasses and contact lenses and lens solutions
b) which does not achieve its primary intended action in or on the human body by
pharmacologic, immunologic or metabolic means but which may be assisted in
its intended function by such means.
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