Document ID: chunk:federal_register_of_legislation:F2025L00198:reg:12
Version: federal_register_of_legislation:F2025L00198
Segment Type: reg
Provision Reference: reg 12
Character Range: 18514–20454

12  Listing criteria for medical devices to be listed in Part A of Schedule 1
 (1) A medical device must not be listed in Part A of Schedule 1 unless subsections (2), (3), (4) and (5) are satisfied.
 (2) The medical device:
 (a) must be an implantable medical device, or an active implantable medical device, that is designed to:
 (i) replace an anatomical body part; or
 (ii) combat a pathological process; or
 (iii) modulate a physiological process; or
 (b) must:
 (i) be specifically designed as an integral single‑use aid and be essential for implanting a device mentioned in paragraph (a); and
 (ii) be designed for use for the patient in whom the device mentioned in paragraph (a) is intended to be implanted; or
 (c) must be:
 (i) critical to the continued functioning of an implanted device mentioned in paragraph (a); and
 (ii) only suitable for use by the patient in whom the device mentioned in paragraph (a) is implanted.
Note: The alternatives in paragraphs 12(2)(b) and (c) will not apply unless a device (the listed device) mentioned in paragraph 12(2)(a) is listed in Schedule 1 (or will be listed in Schedule 1 following a successful listing application or variation application) and the device mentioned in paragraphs (b) and (c) is designed to be used with the listed device.
 (3) The medical device must be a medical device that is not used solely for diagnosis, prediction, or prognosis.
 (4) The medical device must be for a specific treatment and indication.
 (5) Both of the following must be satisfied:
 (a) the medical device must have been compared to:
 (i) devices that are listed in Schedule 1; or
 (ii) alternative treatments;
 (b) the comparison must demonstrate that:
 (i) the medical device is no less clinically effective than the devices listed in Schedule 1 or the alternative treatments; and
 (ii) the benefit amount for the medical device is proportionate to the clinical‑effectiveness of the device.