PUBLICATION OF CANCELLATION OF ENTRIES FOR KINDS OF MEDICAL DEVICES
FROM THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
SECTION 41GP OF THE THERAPEUTIC GOODS ACT 1989
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) of the Act:
ARTG entry of a kind of medical device: Driver/extractor
ARTG number: 194375
Sponsor: Minimax Implant Pty Ltd
Manufacturer: Dentium Co Ltd (Republic of Korea)
Date cancelled: 01 March 2013
Date of effect of cancellation: 05 April 2013
Reasons:
The sponsor of the medical device has not complied with the condition of inclusion relating to the Essential Principles and the Conformity Assessment Procedures applied to this kind of device.
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
1 March 2013