THE Therapeutic Goods
Administration (TGA) has said
it will audit all applications for
medical devices that use supporting
evidence from one of eight
European notified bodies.
This follows a British Medical
Journal article, ‘How a fake hip
showed up the failings of the
European device regulation’, which
questioned whether the bodies
were likely to be more interested in
repeat business than patient safety.
The TGA said it had received
applications using supporting
evidence from three of these
bodies and that the audits would
be conducted to help the TGA
obtain its own evidence of the
quality of certificates and reports
issued by the notified bodies.
For a full list of the notified
bodies, CLICK HERE.The above article was sent to subscribers in Pharmacy Daily's issue from 18 Aug 14 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 18 Aug 14
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