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 subsection 41GN(1)(b) and (f) of the Act:
ARTG entry of a kind of medical device: endotherapy, forceps
ARTG number: 163380
Sponsor: Hendricks Instruments Service Pty Ltd
Manufacturer: Reda Instrument GmbH (Germany)
Decision date: 02 August 2013
Date of effect: 30 September 2013
Reasons: The device is incorrectly classified (incorrect certification made under section 41FD (c) of the Act); the sponsor details are not available in the device information (failure to comply with a condition of inclusion imposed under section 41FO of the Act); the information supplied with the device is non compliant with the essential principles of the Regulations (incorrect certification made under section 41FD(d) of the Act); failure to provide evidence that the conformity assessment procedures have been applied to the device (incorrect certification made under section 41FD(f) of the Act).
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
2 August 2013