Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 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

                    (ca)  the kind of medical device is covered by an exemption under paragraph 41HA(1)(b); 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)  the person contravenes a direction, or a condition of a direction, given to the person under subsection 42DV(1) in relation to the advertising of the kind of device and the Secretary is satisfied that the contravention is significant; or

                    (ga)  if the person is a body corporate--a related body corporate of the person contravenes a direction, or a condition of a direction, given to the related body corporate under subsection 42DV(1) in relation to the advertising of the kind of device and the Secretary is satisfied that the contravention is significant; or

                     (h)  there is a breach, involving the kind of device, of an applicable provision of the Therapeutic Goods Advertising Code or any other requirement relating to advertising applicable under Part 5-1 or 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.



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