THE TGA has published a proposal
paper for changes to premarket
assessment requirements for
medical devices.
The proposal paper is seeking to:
refine a risk-based approach to
regulation; ensure that the TGA
undertakes a more comprehensive
review of higher risk medical
devices, in particular implantable
and surgically invasive medical
devices intended for long term use;
increase transparency and
accountability of the TGA's decision
making; and allow Australian
manufacturers of lower risk medical
devices to have the option of
European Conformity assessment
for supply of their devices in
Australia.
Interested parties should respond
by close of business Friday 15
March 2013, see www.tga.gov.au.The above article was sent to subscribers in Pharmacy Daily's issue from 15 Jan 13 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 15 Jan 13
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