Spotlight on Australia: Life and Health Sciences
Four types of therapeutic goods
Medicine
Products that act by pharmacological, chemical,
immunological or metabolic means in or on the
body of a human.
(includes biological medicines e.g. monoclonal
antibodies, vaccines that do not contain human
cells, plasma derivatives, recombinant products).
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Biological
Product made from, or that contains, human
cells or human tissues, or live animal cells,
tissues or organs and that is used to:
Treat or prevent disease, ailment, defect or
injury
Diagnose a condition of a person
Test the susceptibility of a person to disease
Replace of modify a person's body parts
(unless excluded or regulated as therapeutic
goods, but not as biologicals)
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After the physiological processes of a person
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Medical Device
Any instrument, apparatus, appliance, material or
other article intended to be used for human beings
for the purpose of one or more of the following:
Diagnosis, prevention, monitoring, treatment or
alleviation of disease
•
Diagnosis, monitoring, treatment, alleviation
of or compensation for an injury or handicap
Investigation, replacement or modification of the
anatomy or of a physiological process
Control of conception.
And that that does not achieve its principal intended
action in or on the human body by pharmacological,
immunological or metabolic means, but that may be
assisted in its function by such means.
Or an accessory to such an instrument, apparatus
appliance, material or other article.
Other Therapeutic Goods
Product that is not regulated specifically as a
medicine, biological or medical device.
(includes sterilants,
disinfectants and tampons)
MyMedical
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