Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41GM

Cancellation of entries of kinds of medical devices from the Register after section 41JA notice

  (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)   the Secretary gives to the person a notice under section   41JA requiring the person to give to the Secretary information or documents relating to the kind of device; and

  (b)   the notice under section   41JA is given for the purposes of ascertaining whether any of the certifications by the person under section   41FD in relation to the kind of device are incorrect; and

  (c)   the person fails to comply with the notice under section   41JA within a further 10 working days from the day specified in that notice.

  (2)   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 gives to the person a notice under section   41JA requiring the person to give to the Secretary information or documents relating to whether medical devices of that kind are being:

  (i)   supplied in Australia; or

  (ii)   imported into Australia; or

  (iii)   exported from Australia; and

  (b)   either:

  (i)   the information or documents given are to the effect that medical devices of that kind are not being supplied in Australia, imported into Australia or exported from Australia; or

  (ii)   the person fails to comply with the notice under section   41JA within a further 10 working days from the day specified in that notice.


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