Document ID: chunk:federal_register_of_legislation:F2025L00198:reg:15
Version: federal_register_of_legislation:F2025L00198
Segment Type: reg
Provision Reference: reg 15
Character Range: 22321–24672

15  Listing criteria for medical devices to be listed in Part D of Schedule 1

Criteria 1 – comparable medical device to listings under Part D of the former Prescribed List

        1.     A medical device must not be listed in Part D of Schedule 1 unless subsections (2), (3) and (4) are satisfied.

        1.       For a medical device that would be a new Part D listing — the listing application or variation application relating to the medical device must request listing in one of the categories, subcategories, groups, subgroups, or suffixes specified in Part D of the former Prescribed List.

            Note: The Prescribed List groups medical devices according to similarity in characteristics, functionality and clinical effectiveness. These grouping are, in descending order of generality: categories, subcategories, groups, subgroups and suffixes.

            This criterion requires that listing and variation applications for Part D must seek listing of the medical device in a category, subcategory, group, subgroup or suffix (as applicable) that existed in Part D of Schedule 1 immediately before the former Prescribed List was repealed and cannot seek establishment of a new category, subcategory, group, subgroup or suffix in Part D.

             The former Prescribed List can be located free of charge on the Federal Register of Legislation at www.legislation.gov.au.

        1.       The medical device must be comparable to a listed item in Part D of Schedule 1.

Criteria 2 – comparison of clinical effectiveness and proportionality of benefit amount
(4) Both of the following must be satisfied:
 (a) the medical device must have been compared to alternative devices listed in Schedule 1;
 (b) the comparison must demonstrate that:
 (i) the medical device is no less clinically effective than the alternative devices; and
 (ii) the benefit amount for the medical device is proportionate to the clinical‑effectiveness of the medical device.

       (5) In this section new Part D listing means a medical device that would be listed for the first time in Part D of Schedule 1 on or after 1 March 2025, or the item in Part D relating to the medical device would be varied on or after 1 March 2025 as the result of a variation application.

Part 4—Cost‑recovery fees

Division 1—Cost‑recovery fees relating to medical devices