TGA examines medical apps
September 16, 2013
The Therapeutic Goods
Administration has launched a
new online guide to the regulation
of medical software, saying that
the rapid evolution of healthrelated
smartphone and tablet
apps “presents new and complex
challenges for the TGA and
regulatory agencies internationally”.
The document clarifies that
software products are considered
to be medical devices if they are
intended to be used for diagnosis,
prevention, monitoring, treatment
or alleviation of disease.
This would include apps which
do blood glucose analysis, monitor
patients or other devices, which
would be considered within the
medical devices regulations.
However the TGA says that many
mobile apps are simply sources of
information, and it doesn’t have a
role in regulating advice to health
professionals or consumers other
than in relation to the advertising
of therapeutic goods, labelling and
instructions for use.
CLICK HERE for more details.
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