Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 2/26)
Character Range: 624110–632132

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 item 2.2 of this Schedule.
1.4     Considering a submission to the Secretary in relation to a proposed suspension of a conformity assessment certificate, including a conformity assessment certificate for an IVD medical device                                                                                                                                                     Subsection 41EN(2) and paragraph 63(2)(h) of the Act                                                   For a medical device, other than an IVD medical device—the fee applicable under item 1.14 to the kind of work to be undertaken
                                                                                                                                                                                                                                                                                                                                                                                                                                                                  For an IVD medical device—the fee applicable under item 1.14A, 1.14AA, 1.14B or 1.14C (as the case may be) to the kind of work to be undertaken
1.4A    Application for full designation conformity assessment body determination                                                                                                                                                                                                                                                                          Paragraph 41EWA(3)(d) of the Act                                                                       5,322
1.4B    Application for partial designation conformity assessment body determination (full QMS)                                                                                                                                                                                                                                                            Paragraph 41EWA(3)(d) of the Act                                                                       2,926
1.4C    Application for partial designation conformity assessment body determination (partial QMS or partial devices)                                                                                                                                                                                                                                      Paragraph 41EWA(3)(d) of the Act                                                                       2,926
1.4D    Assessment of application for full designation conformity assessment body determination                                                                                                                                                                                                                                                            Paragraph 41EWA(3)(g) of the Act                                                                       86,903
1.4E    Assessment of application for partial designation conformity assessment body determination (full QMS)                                                                                                                                                                                                                                              Paragraph 41EWA(3)(g) of the Act                                                                       62,380
1.4F    Assessment of application for partial designation conformity assessment body determination (partial QMS or partial devices)                                                                                                                                                                                                                        Paragraph 41EWA(3)(g) of the Act                                                                       62,380
1.5     Application for the following kinds of medical devices to be included in the Register:                                                                                                                                                                                                                                                             Paragraph 41FDB(2)(b) of the Act
        (b) a Class III medical device;                                                                                                                                                                                                                                                                                                                                                                                                                           1,483
        (c) a Class IIb medical device;                                                                                                                                                                                                                                                                                                                                                                                                                           1,150
        (d) a Class IIa medical device;                                                                                                                                                                                                                                                                                                                                                                                                                           1,150
        (e) a Class I medical device that the manufacturer intends to be supplied in a sterile state or that has a measuring function, except a device that is intended by the manufacturer to be for export only;                                                                                                                                                                                                                                                602
        (f) a Class I medical device that is intended by the manufacturer to be for export only;                                                                                                                                                                                                                                                                                                                                                                  96
        (g) a Class I medical device except one described in paragraph (e) or (f);                                                                                                                                                                                                                                                                                                                                                                                602
        (h) an IVD medical device, including a Class 4 in‑house IVD medical device, but not a device that is intended by the manufacturer to be for export only or a Class 2 IVD medical device that was, immediately before the commencement of the Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015:                                                                                                         1,150
        (i) included in the Register; and
        (ii) classified as a Class 3 IVD medical device because of subclause 1.3(2) of Schedule 2A (as in force immediately before the commencement of that regulation)
              Note: Paragraph (h)—there is no fee for an