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Custom Made Medical Devices

The Therapeutic Goods Administration has advised, that as of 25th of February, 2021, the way that custom made medical devices are regulated is changing, and they are introducing a new framework for regulating personalised medical devices.    Given that many items of assistive technology are considered medical devices, how this impacts on your area of practice may require further investigation, and more information on the framework and how custom made medical devices are regulated is available at: https://www.tga.gov.au/resource/personalised-medical-devices-including-3d-printed-devices

Please undertake the necessary research and investigation if you think this applies to your individual, or your workplace circumstance. 

From the TGA website on custom made medical devices, they offer the following definition. 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.”

Other information on the TGA website advised that a person who adapts a medical device for an individual patient does not meet the legislative definition of a manufacturer providing the adaptation does not alter its intended purpose and custom made devices do not include off the shelf medical devices that have been adapted to accommodate an individual patient.  Devices that require modification must be included in the Australian Register of Therapeutic Goods (ARTG) before they are supplied. 

Information for health professionals can be found at: https://www.tga.gov.au/custom-made-medical-devices