Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:5:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 5 (pt 3/26)
Character Range: 631874–640003

(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 application to include in the Register a Class 2 IVD medical device mentioned in the paragraph.
        (i) an IVD medical device that is intended by the manufacturer to be for export only                                                                                                                                                                                                                                                                                                                                                                      96
1.5A    Application for medical devices (priority applicant) determination in relation to a medical device                                                                                                                                                                                                                                                 Paragraph 41FKA(3)(d) of the Act                                                                       11,641
1.6     Considering submissions to the Secretary in relation to a proposed suspension of a kind of medical device, including an IVD medical device, from the Register                                                                                                                                                                                      Subsection 41GB(2) and paragraph 63(2)(h) of the Act                                                   The fee applicable under item 1.14 to the kind of work to be undertaken
1.6A    Request for the revocation of the cancellation of an entry of a kind of medical device from the Register:                                                                                                                                                                                                                                          Paragraph 41GLA(1)(c) of the Act
        (a) if the request relates to one entry;                                                                                                                                                                                                                                                                                                                                                                                                                  181
        (b) if the request relates to more than one entry                                                                                                                                                                                                                                                                                                                                                                                                         181 for the first entry plus 57 for each additional entry
1.6B    Request for the revocation of the cancellation of an entry of a kind of medical device from the Register:                                                                                                                                                                                                                                          Paragraph 41GLB(1)(d) of the Act
        (a) if the request relates to one entry;                                                                                                                                                                                                                                                                                                                                                                                                                  181
        (b) if the request relates to more than one entry                                                                                                                                                                                                                                                                                                                                                                                                         181 for the first entry plus 57 for each additional entry
1.7     Application for approval to use a specified kind of  medical device, including an IVD medical device, solely for experimental purposes in humans                                                                                                                                                                                                   Paragraph 41HB(5)(c) of the Act                                                                        21,697
1.7A    Request to vary a medical device, or kind of medical device, specified in an approval to use that device or kind of device solely for experimental purposes in humans, or to vary the conditions of such an approval                                                                                                                               Paragraph 41HB(8)(e) of the Act                                                                        5,922
1.8     Each of the following:                                                                                                                                                                                                                                                                                                                             Paragraph 63(2)(h) of the Act, and Schedule 4, item 2.3, paragraphs (b) and (ha) of these Regulations
        (a) notification of intention to sponsor a clinical trial of a medical device, including an IVD medical device, to be used solely for experimental purposes in humans, at a trial site;                                                                                                                                                                                                                                                                   429
        (b) each notification of an additional trial site or additional trial sites for the clinical trial                                                                                                                                                                                                                                                                                                                                                        429
1.9     Conformity assessment—initial assessment under conformity assessment procedures for a medical device, other than 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