Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41fn:p2
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41FN (pt 2/2)
Character Range: 73968–75547

including a written agreement with the manufacturer of the kind of devices setting out the matters required by the regulations, to ensure that such information can be obtained from the manufacturer within the period specified in the regulations; and
 (c) at any time while the inclusion in the Register has effect, the person in relation to whom the kind of device is included in the Register will, if asked to do so by the Secretary, give the information to the Secretary; and
 (d) the person in relation to whom the kind of device is included in the Register will give information of a kind mentioned in subsection 41MP(2) to the Secretary within the period specified in the regulations; and
 (e) the person in relation to whom the kind of device is included in the Register will give the manufacturer of the kind of medical device information relevant to:
 (i) the manufacturer's obligations under the conformity assessment procedures; and
 (ii) whether medical devices of that kind comply with the essential principles.

 (4) The regulations may prescribe the amount, standard or kind of information or evidence required for the purposes of paragraphs (3)(c), (d) and (e).

Advertising material

 (5) The inclusion of a kind of medical device in the Register is subject to a condition that advertising material relating to medical devices of that kind is consistent with the intended purpose as certified under section 41FD.

Conditions do not limit other conditions

 (6) A condition imposed under this section is in addition to any conditions imposed under this Division.