12Listing criteria for medical devices to be listed in Part A of Schedule 1

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.