New implant rules
July 2, 2012
THE Therapeutic Goods
Administration has announced
significant changes to the
regulation of joint implants, with
hip, knee and shoulder implants to
be reclassified as high risk Class III
medical devices.
The move is effective
immediately, with Parliamentary
Secretary for Health and Ageing,
Catherine King, saying the new
classification “will bring greater
rigour to the way the Therapeutic
Goods Administration assesses
these devices before they can be
used in Australia.
“It will also ensure an improved
level of monitoring is undertaken
once the product is on the market,
and will allow easier product
recall,” King added.
The move follows extensive
stakeholder consultation, and
includes a two year period for
manufacturers and suppliers to
transition to the new arrangements.
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