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) (f) of the Act:
ARTG entry of a kind of medical device: Filter, humidifier, heat/moisture exchanger
ARTG number: 198267
Sponsor: LMA PacMed Pty Ltd
Manufacturer: Atos medical AB (Sweden)
Date cancelled: 8 March 2013
Date of effect of cancellation: 19 April 2013
Reasons:
The sponsor of the medical device has not complied with the condition of inclusion relating to the Essential Principles.
The certification made in the application to include this kind of device in the Register are not correct in relation to the intended purpose of the device. The intended purpose in the device product information is different than that stated in the ARTG Inclusion.
(Signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
8 March 2013