Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 1/26)
Character Range: 616458–624351

Schedule 5—Fees
(regulation 9.1)

Part 1—General

Item    Matter                                                                                                                                                                                                                                                                                                                                             Provision of Act or these Regulations                                                                  Amount ($)
1.1     Application for conformity assessment certificate                                                                                                                                                                                                                                                                                                  Paragraph 41EB(2)(a) of the Act                                                                        1,483
1.1A    Application for conformity assessment (priority applicant) determination in relation to a medical device                                                                                                                                                                                                                                           Paragraph 41ECA(3)(d) of the Act                                                                       11,065
1.2     (a) Review of conformity assessment certificate—surveillance assessment for conformity assessment certificate issued under conformity assessment procedures set out in Schedule 3, Part 1, 4 or 5                                                                                                                                                  Subsection 41EJ(4) of the Act                                                                          9,733
              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.
        (b) Review of conformity assessment certificate for an IVD medical device—surveillance assessment for conformity assessment certificate issued under conformity assessment procedures set out in Schedule 3, Part 1 or 4                                                                                                                                                                                                                                  9,786
1.3     Review of conformity assessment certificate for a medical device, other than an IVD medical device—in relation to certification of compliance with the essential principles for conformity assessment certificate issued under conformity assessment procedures set out in:                                                                        Subsection 41EJ(4) of the Act
        (a) Schedule 3, clause 1.6; or                                                                                                                                                                                                                                                                                                                                                                                                                            59,511
        (b) Schedule 3, Part 2 (including management of testing, analysis, and reporting on examination of the type)                                                                                                                                                                                                                                                                                                                                              45,869
              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 (b), 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.
1.3A    Review of conformity assessment certificate for an IVD medical device in relation to certification of compliance with the essential principles for conformity assessment certificate issued under conformity assessment procedures set out in:                                                                                                     Subsection 41EJ(4) 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 – Immunohaematology 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