Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41fd
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41FD
Character Range: 63537–65343

41FD  Matters to be certified

  The applicant must certify that:
 (a) devices of the kind in question are medical devices; and
 (b) devices of that kind are intended for a specified purpose, as ascertained under subsection 41BD(2); and
 (c) the kind of device is correctly classified according to the medical device classifications; and
 (d) devices of that kind comply with the essential principles; and
 (e) the applicant:
 (i) has available sufficient information to substantiate that compliance with the essential principles; or
 (ii) has procedures in place, 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
 (f) an appropriate conformity assessment procedure has been applied to devices of that kind; and
 (g) the applicant:
 (i) has available sufficient information to substantiate the application of those conformity assessment procedures; or
 (ii) has procedures in place, 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
 (h) devices of that kind comply with every requirement (if any) relating to advertising applicable under the regulations; and
 (i) devices of that kind do not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and
 (j) the information included in or with the application is complete and correct.

Note: See section 41BH on compliance with the essential principles and section 41BI on applying the conformity assessment procedures.