Documents to support your medical device inclusion

What documents you need to support the inclusion of a medical device, including IVDs, in the Australian Register of Therapeutic Goods (ARTG).

Last updated

27 April 2023

Before applying, make sure you’ve got the right Manufacturer’s Evidence. It’s also a good idea to ask the manufacturer for a Declaration of Conformity to support your medical device or IVD device. We may request this documentation at any time.

For details on the documentation required for the inclusion process and maintaining your ARTG entry, refer to the Supporting documentation for inclusion of a medical device.

Does your device require conformity assessment? Read the information on Conformity Assessment and overseas market authorisation prior to application, to ensure you submit the device under the right classification with the right conformity assessment documentation.

Supporting evidence

Manufacturer Evidence for medical devices

Medical device and in vitro diagnostic (IVD) applications require a Manufacturer's Evidence application.
Providing documentation for including medical devices in the ARTG

Guidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).

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Documents to support your medical device inclusion

Supporting evidence

Manufacturer Evidence for medical devices

Providing documentation for including medical devices in the ARTG