Document ID: chunk:federal_register_of_legislation:F2025L00198:reg:14
Version: federal_register_of_legislation:F2025L00198
Segment Type: reg
Provision Reference: reg 14
Character Range: 20677–22321

14  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 14(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.