Australia Therapeutic Goods Act 1989 s41HA-41HD-41MO: Exempt devices, special access, clinical trial, authorised prescriber and shortage approvals: deal under each exemption, approval or authority only within its conditions, use experimental devices only under the prescribed conditions, and notify supplies under prescriber rules within 28 days

What does s41HA-41HD-41MO require?

Regulations may exempt devices from the Register requirements subject to prescribed conditions (Medical Devices Regulations Schedule 4). The Secretary may approve importing, exporting or supplying an unapproved device for use in treating a person (approval only to health practitioners) or solely for experimental use in humans, subject to conditions including charging, and experimental users are bound by prescribed conditions on preconditions, principles, monitoring and when to stop. Authorised prescribers (medical practitioners in a prescribed class with ethics committee approval, unless an exception applies) may supply specified devices to specified recipients under conditions; health practitioners authorised by ministerial rules must notify each supply to the Secretary on the approved form within 28 days (strict liability, 10 penalty units). Section 41HD approvals allow import and supply of substitutes where ARTG devices are unavailable or in short supply. Supplying under an authority otherwise than in accordance with it, its conditions or the regulations is an offence tiered by harm (section 41MO), and breaching approval or exemption conditions is an offence under section 41MN.