Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41fd:p2
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41FD (pt 2/2)
Character Range: 706135–707577

prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions:
 (i) if those prohibitions cover imports—any imports into Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and
 (ii) if those prohibitions cover exports—any exports from Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and
 (iii) if those prohibitions cover manufacture—any manufacture in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and
 (iv) if those prohibitions cover supplies—any supplies in Australia of devices of that kind by, or on behalf of the applicant, will not contravene those conditions; and
 (i) devices of that kind do not contain substances that are prohibited imports for the purposes of the Customs Act 1901; and
 (ia) devices of that kind are not to be used exclusively for one or more of the purposes specified under section 41BEA; and
 (j) the information included in or with the application is complete and correct.
Note: See section 41BH for when a medical device complies with the essential principles, section 41BI for when conformity assessment procedures are taken not to have been applied to a medical device and section 41BIA for when requirements comparable to those procedures are taken not to have been applied to a medical device.