Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41gl
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41GL
Character Range: 86599–88537

41GL  Immediate cancellation of entries of kinds of medical devices from the Register

  The Secretary may, by written notice given to the person in relation to whom a kind of medical device is included in the Register, cancel the entry of the kind of device from the Register if:
 (a) the Secretary is satisfied that there would be an imminent risk of death, serious illness or serious injury if the kind of device continues to be included in the Register; or
 (b) devices of that kind are no longer therapeutic goods; or
 (c) devices of that kind are no longer medical devices; or
 (d) the person requests in writing the cancellation of the entry of the kind of device from the Register; or
 (e) the Secretary is satisfied that a statement made in or in connection with:
 (i) the application for including the kind of device in the Register; or
 (ii) the certification or purported certification under section 41FD relating to the application;
  was false or misleading in a material particular; or
 (f) the annual charge payable under subsection 4(1B) of the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of device in the Register is not paid within 20 working days after it becomes payable; or
 (g) both of the following apply:
 (i) under the regulations, an authority constituted by or under the regulations gives a direction to, or makes a requirement of, the person in relation to an advertisement of the kind of device to ensure that advertising complies with the Therapeutic Goods Advertising Code;
 (ii) the person does not comply with the direction or requirement; or
 (h) there is a serious breach, involving the kind of device, of the requirements relating to advertising applicable under the regulations, and the Secretary is satisfied that:
 (i) the breach is significant; and
 (ii) as a result of the breach, the presentation of devices of that kind is misleading to a significant extent.