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)(f) of the Act:
ARTG entry of a kind of medical device: Suction tip, general-purpose, single use
ARTG number: 198348
Sponsor: Abby & Jess Pty Ltd
Manufacturer: Fomed Industries Inc (China-Peoples Republic of)
Date cancelled: 9 May 2013
Date of effect of cancellation: 21 June 2013
Reasons:
(1) The device product information fails to comply with the requirements of Essential Principle No 13 of the Therapeutic Goods (Medical Devices) Regulations 2002. Hence the certification made at the time of application under section 41FD(d) of the Act is incorrect.
(2) The device has been incorrectly classified as a Class I medical device under the rules of Schedule 2 of the Regulations. Hence the certification made at the time of application under section 41FD(c) of the Act is incorrect.
Under the provisions of section 41GN(1) of the Act these are grounds for cancellation of the Entry.
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
09 May 2013