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Under Regulation 10.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 you are required to notify the TGA of specific details about a custom-made medical device if you are:

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

Notification is required within two months of manufacture or initial supply of the custom-made medical device.

This online notification form is provided for your convenience to simplify this notification process.

What are custom-made medical devices?

Custom made medical devices are defined in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) as medical devices that are:

  • made specifically in accordance with a request by a health professional specifying its design characteristics or construction.
  • intended to be used only in relation to a particular individual, or by a health professional to meet special needs arising in the course of his or her practice.

Show more information about Examples of custom made medical devices include:

  • dental appliances such as crowns, bridges and dentures
  • prosthetic or glass eyes
  • orthopaedic or pedorthic footwear
  • prosthetic limbs
  • prescription glasses.

Show more information about Are medical devices that are adapted for an individual considered to be custom made?

Custom made medical devices do not include medical devices that have been adapted or modified to accommodate an individual patient. However, the device that requires modification is also required to be included on the Australian Register of Therapeutic Goods (ARTG) before it is supplied.

It is important to note that the person who adapts a medical device for an individual patient is not considered to be a manufacturer of a medical device if the adaptation does not alter its intended purpose. This exclusion is covered under subsection 41BG(3) of the Therapeutic Goods Act 1989 (the Act).

Notification form: Custom-made medical devices

As a laboratory owner, Dentist or any other medical professional if you import a custom made device you must register with the TGA.


Go to the following link:

https://www.tga.gov.au/custom-made-medical-devices