About section 41HD approvals for import and supply

Approvals under section 41HD of the Therapeutic Goods Act 1989 (the Act) allow sponsors to import and supply nominated medical devices in a supply emergency situation under special exemption and subject to conditions.

Approvals may be granted if:

• The kinds of medical devices included in the Australian Register of Therapeutic Goods (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 ARTG. 
• The medical device is necessary in the interests of public health.

As of 1 May 2026, supply of medical devices under critical supply disruption can be approved under section 41HD for all classifications of medical devices and in vitro diagnostic (IVD) medical devices, being:

• Class I, Class IIa, Class IIb, or Class III medical devices; and 
• Class 1, Class 2, Class 3, or Class 4 IVD medical devices.

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. Conditions of the exemption may include the requirement to:

• inform us of any variation or if any information about the medical device becomes out of date 

• report any adverse events to us 

• record the source and supply of the medical devices

• have evidence that the device is compliant with the Essential Principles and conformity assessment 

• provide samples of the medical device to us

• labelling and instructions for use must be in English and include the name and address of the approval holder

• inform us of any supply issues associated with the medical devices

• comply with relevant advertising requirements

Devices approved for supply under section 41HD