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

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. (2) 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.

Note: 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or suffix (as applicable) that existed in Part D of Schedule 1 immediately before the former Prescribed List was repealed and cannot seek establishment of a new category, subcategory, group, subgroup or suffix in Part D.

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

(3) 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 November 2024, or the item in Part D relating to the medical device would be varied on or after 1 November 2024 as the result of a variation application.