Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p5
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 5/26)
Character Range: 648176–655698

Schedule 3, Part 5                                                                                                                                                                                                                                                                                                                                                                                                                                    15,254
              Note 1: If the assessment involves an assessment of a medicinal component, an additional fee is payable—see item 1.11.
              Note 2: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable—see item 1.12 and clause 2.1 of this Schedule.
              Note 3: For an assessment under paragraph (c), an additional fee to cover the costs of testing the relevant kind of medical device, or quality management system, is also payable—see clause 2.2 of this Schedule.
1.10A   Conformity assessment—assessment because of changes or proposed changes to an IVD medical device or quality management system applying to that device, under conformity assessment procedures set out in:                                                                                                                                          Subsections 41LA(1) and (2) of the Act
        (a) Schedule 3, Part 1—Full Quality Management System; or                                                                                                                                                                                                                                                                                                                                                                                                 20,174
        (b) Schedule 3, clause 1.6—Design Examination; or                                                                                                                                                                                                                                                                                                                                                                                                         42,990
        (c) Schedule 3, clause 1.6—Design Examination – Immunohaematology reagent medical devices; or                                                                                                                                                                                                                                                                                                                                                             10,442
        (d) Schedule 3, clause 1.6—Abridged Design Examination – previously registered IVDs; or                                                                                                                                                                                                                                                                                                                                                                   2,533
        (e) Schedule 3, Part 2—Type Examination; or                                                                                                                                                                                                                                                                                                                                                                                                               27,780
        (f) Schedule 3, Part 4—Production Quality Management System                                                                                                                                                                                                                                                                                                                                                                                               17,725
              Note 1: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable—see item 1.12 and clause 2.1 of this Schedule.
              Note 2: For an assessment under Schedule 3, Part 2, an additional fee to cover the costs of testing the relevant kind of medical device, or quality management system, is also payable—see clause 2.2 of this Schedule.
1.11    If an assessment of a medical device involves an assessment of the medicinal component of the device—for an assessment of the data relating to the medicinal component (and in addition to the fee required under item 1.2, 1.3, 1.9 or 1.10)                                                                                                      Subsections 41EJ(4) and 41LA(1) and (2) of the Act                                                     The fee applicable under item 4, or paragraph
                                                                                                                                                                                                                                                                                                                                                                                                                                                                  (b) or (d) of item 5, of Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990
1.12    If a supplementary assessment of a medical device is required, in addition to the assessment mentioned in item 1.2, 1.3, 1.9, 1.9A, 1.10 or 1.10A                                                                                                                                                                                                  Subsections 41EJ(4) and 41LA(1) and (2) of the Act                                                     496 for each hour for each assessor involved
              Note: For an assessment conducted outside Australia, an additional fee is payable—see clause 2.1 of this Schedule.
1.13    Application audit assessment, Level 1—verification of sponsor's application and evidence of conformity                                                                                                                                                                                                                                             Subsections 41LA(3) and (4) of the Act                                                                 4,554
1.14    Application audit assessment, Level 2—for Level 1 activities and review of evidence of conformity for the following kinds of medical device:                                                                                                                                                                                                       Subsections 41LA(3) and (4) of the Act
        (a) Class III medical devices (other than IVD medical devices);                                                                                                                                                                                                                                                                                                                                                                                           16,752
        (b) all other medical devices (other than