Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p6
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 6/26)
Character Range: 654862–662154

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 IVD medical devices)                                                                                                                                                                                                                                                                                                                                                                                            4,188
1.14A   Application audit assessment for the following kinds of medical devices:                                                                                                                                                                                                                                                                           Subsections 41LA(3) and (4) of the Act
        (a) Class 1 and Class 2 IVD medical devices;                                                                                                                                                                                                                                                                                                                                                                                                              7,734
        (b) Class 3 IVD medical devices, other than devices to which item 1.14AA applies;                                                                                                                                                                                                                                                                                                                                                                         23,439
        (c) Class 4 IVD medical devices, other than:                                                                                                                                                                                                                                                                                                                                                                                                              23,439
        (i) Class 4 IVD medical devices that are immunohaematology reagent IVD medical devices; or
        (ii) devices to which item 1.14AA, 1.14B or 1.14C applies;
        (d) Class 4 IVD medical devices that are immunohaematology reagent IVD medical devices                                                                                                                                                                                                                                                                                                                                                                    17,402
1.14AA  Application audit assessment for Class 3 IVD medical devices or Class 4 IVD medical devices (other than devices to which paragraph (d) of item 1.14A, or item 1.14C, applies), where the devices are not subject to laboratory testing as part of the auditing of the application                                                                  Subsections 41LA(3) and (4) of the Act                                                                 14,865
1.14B   Application audit assessment for Class 4 in‑house IVD medical devices (other than a device to which item 1.14AA or 1.14C applies)                                                                                                                                                                                                                  Subsections 41LA(3) and (4) of the Act                                                                 23,439
1.14C   Application audit assessment for Class 4 in‑house IVD medical devices that are immunohaematology reagent IVD medical devices                                                                                                                                                                                                                       Subsections 41LA(3) and (4) of the Act                                                                 17,402
1.15    Application for consent of Secretary to importation into Australia, supply for use in Australia, or exportation from Australia of a medical device, including an IVD medical device:                                                                                                                                                               Sections 41MA and 41MAA and paragraph 63(2)(h) of the Act
        (a) for an application relating to a medical device that is not included in the Register or to a medical device to which a single entry in the Register relates; or                                                                                                                                                                                                                                                                                       Subject to regulation 9.1AA, 565 (for all the devices to which the application relates)
        (b) for an application relating to medical devices to which both of the following apply:                                                                                                                                                                                                                                                                                                                                                                  Subject to regulation 9.1AA, 565 for the first entry plus 113 for each additional entry
        (i) there are separate entries in the Register in relation to the devices;
        (ii) the way in which the devices do not comply with essential principles is the same for all the devices
1.16    Intermediate stage assessment or verification procedures to be carried out in relation to the application of the conformity assessment procedures to an article                                                                                                                                                                                    Subregulation 3.13(1) of these Regulations                                                             The fee applicable under item 1.9, 1.10 or 1.12 to the kind of work to be undertaken
1.17    Notification by a manufacturer, under subclause 6A.2(1) of Part 6A of Schedule