Custom-made Medical Devices Notification

Custom-made medical devices information

Important note: On 25 February 2021 a new framework for regulating personalised medical devices commenced. The framework includes a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG). More information about these changes is available on our website.

Under Regulation 10.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 you are required to notify the TGA of specific details if you are:

• the Australian manufacturer of a kind of custom-made medical device; or
• the Australian sponsor (supplier) of a kind of custom-made medical device that was manufactured overseas.

Notification is required within two months of the first manufacture or initial supply of the kind of device.

Notification must be submitted using this form.

Each notification submitted should be for one (1) kind of device only.

Providing information that is false or misleading to a Commonwealth entity or in connection with a Commonwealth law is a serious offence subject to criminal penalties under the Criminal Code Act 1995.