Commonwealth Consolidated Acts

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Suspension where other certificates or documents are suspended

             (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, suspend the kind of device from the Register if:

                     (a)  an Australian conformity assessment body certificate that applies to the kind of device is suspended by the Australian conformity assessment body; or

                     (b)  an overseas regulator conformity assessment document that applies to the kind of device is suspended by the overseas regulator.

             (2)  However, before suspending the kind of device from the Register, the Secretary must:

                     (a)  inform the person in writing that the Secretary proposes the suspension 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 suspension.

             (3)  The Secretary is not to make a decision relating to the proposed suspension until the Secretary has had regard to any submissions the person makes under paragraph (2)(b).

             (4)  The Secretary must cause to be published on the Department's website, as soon as practicable after the suspension, a notice setting out particulars of the suspension.

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