COMMONWEALTH OF AUSTRALIA
Department of Health and Ageing
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
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 subsections 41GN(1)(b) and (f) of the Act:
ARTG entry of a kind of medical device: Suction tip, general-purpose, single use
ARTG number: 204303
Sponsor: Danas Dental Supplies Pty Ltd
Manufacturer: Weini Technology Devices Development Co Ltd (China-Peoples Republic of)
Date cancelled: 6 August 2013
Date of effect: 13 September 2013
Reason:
The device is incorrectly classified (the certification made under section 41FD(c) of the Act
is incorrect); the device labelling does not comply with the essential principles (the
certification made under section 41FD(d) of the Act is incorrect); the sponsor is not identified
in the product information (a non compliance with a condition of inclusion imposed under
section 41FO of the Act); failure to provide evidence that the conformity assessment
procedures have been applied to the device (the certification made under sections 41FD(f)
and (g) of the Act is incorrect).
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
6 August 2013