I, Rodolfo Ferrari, delegate of the Secretary to the Department of Health and Ageing for the purposes of section 41GP of the Therapeutic Goods Act 1989 (the Act), hereby publish particulars of the cancellation of the following entry of a kind of medical device from the Australian Register of Therapeutic Goods under subsection 41GN(1)(f) of the Act:
ARTG entry of a kind of medical device: Gauge, depth, dental implant
ARTG number: 202502
Sponsor: Osstem Australia Pty Ltd
Manufacturer: Osstem Implant Co Ltd (Korea- Republic of)
Date of Decision: 26 July 2013
Date of Effect of Cancellation: 20 September 2013
Reason:
The sponsor failed to provide evidence that the manufacturer applied the appropriate
Conformity Assessment procedure to the device. Therefore the certifications made under
section 41FD (f) and(g) of the Act at the time of the application are incorrect.
(signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
26 July 2013