Commonwealth Consolidated Acts Commonwealth Consolidated Acts(1) 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) medical devices that were devices of that kind when the kind of device was included in the Register have changed so those medical devices are no longer devices of that kind; or
(b) the person in relation to whom the kind of medical device is included in the Register refuses or fails to comply with a condition to which that inclusion is subject; or
(c) the Secretary gives to the person a notice under section 41JA:
(i) that requires the person to give to the Secretary information or documents relating to the kind of device; and
(ii) in respect of which section 41GM does not apply;
and the person fails to comply with that notice within a further 10 working days from the day specified in that notice; or
(d) the person contravenes subsection 41MP(1) or 41MPA(1) in relation to the kind of device; or
(e) the Secretary is satisfied that the safety or performance of the kind of device is unacceptable; or
(f) the Secretary is satisfied that any certification, or part of a certification, under section 41FD in relation to the application for inclusion of the kind of device in the Register is incorrect, or is no longer correct, in a material particular; or
(g) a conformity assessment document that applies to the kind of device expires; or
(h) either of the following applies:
(i) an Australian conformity assessment body certificate that applies to the kind of device is revoked by the Australian conformity assessment body;
(ii) an overseas regulator conformity assessment document that applies to the kind of device is revoked by the overseas regulator; or
(i) 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; or
(j) 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; or
(k) either of the following has not been complied with in relation to the kind of device:
(i) an applicable provision of the Therapeutic Goods Advertising Code;
(ii) any other requirement relating to advertising applicable under Part 5 - 1 or the regulations.
(2) However, before cancelling the entry of the kind of device from the Register, the Secretary must:
(a) inform the person in writing that the Secretary proposes the cancellation and set out the reasons for it; and
(b) give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed cancellation.
(3) The Secretary is not to make a decision relating to the
proposed cancellation until the Secretary has had regard to any submissions
the person makes under paragraph (2)(b).