TGA devices update
July 2, 2010
THE Therapeutic Goods
Administration has advised that as
of the beginning of Jul, the
following materials are no longer
considered as ‘Medical Devices’:
• chemical oxygen generators
• in-vivo imaging agents injected,
ingested or otherwise instilled into
the body
• an article that is intended to
administer a medicine in such a
way that the medicine and the
article form a single integral
product in the given combination
and which is not reusable
• articles incorporating tissues,
cells or substances of human
origin, other than medical devices
incorporating stable derivatives of
either human blood or human
plasma that act on, or are likely to
act on, the human body in a way
that is ancillary to the device
• articles incorporating viable
tissues, cells or substances of
animal origin
• hospital grade or household
grade disinfectants that are
claimed to be sterilants, fungicides,
sporicides, tuberculocides or
virucides are no longer considered
medical devices.
For details - www.tga.gov.au.
The above article was sent to subscribers in Pharmacy Daily's issue from 02 Jul 10To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 02 Jul 10
