16Listing criteria for medical devices to be listed in Part C of Schedule 1

16 Listing criteria for medical devices to be listed in Part C of Schedule 1

(1) A medical device must not be listed in Part C of Schedule 1 unless subsections (2) and (3) are satisfied. (2) The medical device must be one of the following: (a) an insulin infusion pump; (b) an electronic device and software designed to control an insulin infusion pump; (c) an implantable cardiac event recorder; (d) a cardiac home/remote monitoring system; (e) an irrigated cardiac ablation catheter; (f) a mapping catheter for catheter cardiac ablation; (g) a patch for cardiac ablation; (h) a monopolar device for surgical cardiac ablation; (i) a bipolar device for surgical cardiac ablation; (j) a system for surgical cardiac ablation; (k) a probe for surgical cardiac ablation; (l) a non‑irrigated cardiac ablation catheter; (m) an intracardiac electrophysiology catheter; (n) a vascular drug eluting balloon catheter; (o) a coronary drug eluting balloon catheter; (p) a radiofrequency delivery device for transurethral water vapour ablation (TUWA).

Note: This instrument may be varied from time to time to add additional devices to, or remove devices from, subsection (2).

(3) Both of the following must be satisfied: (a) the medical device must have been compared to: (i) alternative devices 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 alternative devices or the alternative treatments; and (ii) the benefit amount for the medical device is proportionate to the clinical‑effectiveness of the medical device.