COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
CANCELLATION OF ENTRIES FOR KINDS OF MEDICAL DEVICES
FROM THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
PUBLICATION UNDER SECTION 41GP OF THE ACT
I, Rodolfo Ferrari, delegate of the Secretary of the Department of Health and Ageing for the purposes of section 41GP of the Therapeutic Goods Act 1989 (the Act), hereby publish under section 41GP of the Act particulars of the cancellation of the following entry of a kind of medical device from the Australian Register of Therapeutic Goods (the ARTG).
ARTG number: 208813
Kind of medical device: CAD/CAM unit, orthopaedic [41018]
Sponsor: Biomet Australia Pty Ltd
Manufacturer: Biomet Orthopaedics Inc (United States of America)
Decision Date: 16 August 2013
Date of effect of cancellation: 23 September 2013
Reasons for the cancellation:
The appropriate conformity assessment procedures had not been applied to the device by the
manufacturer, therefore the declaration made under 41FD(f)at the time of the application is incorrect.
The ARTG Entry is cancelled under Section 41GN(1)(f) of the Act.
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary of the Department of Health and Ageing
16 August 2013