Approvals under section 41HD of the Therapeutic Goods Act 1989 allow sponsors to import and supply nominated medical devices in a supply emergency situation under special exemption and subject to conditions.
- The kinds of medical devices included in the ARTG that could act as a substitute are unavailable or in short supply, or may, in the reasonably foreseeable future, become unavailable or be in short supply.
- The medical device is registered and approved for use in at least one foreign country or has an application with a passed preliminary assessment for inclusion into the Australian Register of Therapeutic Goods (ARTG).
- The medical device is necessary in the interests of public health.
Medical devices approved under section 41HD are subject to conditions of exemption imposed by the Secretary and are not considered to be included in the ARTG.
Currently, section 41HD approvals are limited to cannulas for use in cardiac surgery or cardiopulmonary bypass procedures.
Approved Section 41HD medical devices
| Medical device name | Section 41HD approval holder | Approved until | Approval status |
|---|---|---|---|
Andocor Catheters and Cannulae Approved device details - Andocor - BTC Cardio Pty Ltd [PDF, 404.53 KB] | BTC Cardio Pty Ltd | 19 September 2026 | Current |
Product types