COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
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, Jane Cook, delegate of the Secretary to the Department of Health 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 (the ARTG) under paragraph 41GN(1)(b) of the Act:
ARTG entry of kind of medical device: Light, transilluminator
ARTG number: 207079
Sponsor: Biosoft Pty Ltd
Date effective: 4 February 2014
Reasons: As the sponsor did not provide information to substantiate compliance with the essential principles, the sponsor failed to comply with a condition to which the inclusion of the kind of device in the ARTG was subject under s.41FN (3)(a). As the advertising material used for the promotion of the device was not consistent with the intended purposed as certified by the sponsor under section 41FD, the sponsor failed to comply with a condition to which the inclusion of the kind of device was subject under s.41FN(5).
(Signed by)
Dr Jane Cook
Delegate of the Secretary to the Department of Health
28 January 2014