Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p4
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 4/26)
Character Range: 638736–648873

an IVD medical device, set out in:                                                                                                                                                                                                Subsections 41LA(1) and (2) of the Act
        (a) Schedule 3, Part 1; or                                                                                                                                                                                                                                                                                                                                                                                                                                33,516
        (b) Schedule 3, clause 1.6; or                                                                                                                                                                                                                                                                                                                                                                                                                            65,850
        (c) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type); or                                                                                                                                                                                                                                                                                                                                          45,869
        (d) Schedule 3, Part 3 (including management of testing, analysis, and reporting on verification of the type); or                                                                                                                                                                                                                                                                                                                                         32,119
        (e) Schedule 3, Part 4; or                                                                                                                                                                                                                                                                                                                                                                                                                                29,326
        (f) Schedule 3, Part 5                                                                                                                                                                                                                                                                                                                                                                                                                                    25,030
              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) or (d), an additional fee to cover the costs of testing the relevant kind of medical device is also payable—see clause 2.2 of this Schedule.
              Note 4: If the assessment is abridged, a reduced fee is payable—see regulation 9.4.
1.9A    Conformity assessment for an IVD medical device—initial assessment 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                                                                                                                                                                                                                                                                                                                                                                                                 33,623
        (b) Schedule 3, clause 1.6—Design Examination; or                                                                                                                                                                                                                                                                                                                                                                                                         71,650
        (c) Schedule 3, clause 1.6—Design Examination – Immunohaemotology reagent medical devices; or                                                                                                                                                                                                                                                                                                                                                             17,402
        (d) Schedule 3, clause 1.6—Abridged Design Examination – previously registered IVDs; or                                                                                                                                                                                                                                                                                                                                                                   4,222
        (e) Schedule 3, Part 2—Type Examination; or                                                                                                                                                                                                                                                                                                                                                                                                               46,299
        (f) Schedule 3, Part 4—Production Quality Management System                                                                                                                                                                                                                                                                                                                                                                                               29,541
              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 paragraph (e), an additional fee to cover the costs of testing the relevant kind of medical device is also payable—see clause 2.2 of this Schedule.
              Note 3: If the assessment is abridged, a reduced fee is payable—see regulation 9.4.
1.10    Conformity assessment—assessment consequent on change to medical device, other than an IVD medical device, or quality management system applying to medical device, other than an IVD medical device, under conformity assessment procedures set out in:                                                                                           Subsections 41LA(1) and (2) of the Act
        (a) Schedule 3, Part 1; or                                                                                                                                                                                                                                                                                                                                                                                                                                20,196
        (b) Schedule 3, clause 1.6; or                                                                                                                                                                                                                                                                                                                                                                                                                            39,746
        (c) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type); or                                                                                                                                                                                                                                                                                                                                          27,715
        (d) Schedule 3, Part 4; or                                                                                                                                                                                                                                                                                                                                                                                                                                17,402
        (e) 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