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 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 number: 185076
Kind of medical device: compress, hot/cold pack, reusable
Sponsor: Gelpal, Surrey Hills, NSW
Manufacturer: Taiwan Stanch Co Ltd
Decision Date: 13 August 2013
Date of Effect: 24 September 2013
Reasons:
The certification made under section 41FD (d) of the Act at the time of application is incorrect because the product labelling is not compliant with essential principle 13.3 of Schedule 1 of the Regulations.
The certifications made under section 41FD(f) and (g) of the Act at the time of application are incorrect because no evidence was provided to substantiate that the conformity assessment procedures have been applied to the device.
The certification made under section 41FD(h) of the Act at the time of application is incorrect because the promotional material is in breach of the Therapeutic Goods Advertising Code 2007.
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
13 August 2013