Custom-made Medical Device Regulations in Australia
Custom-made medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA). The TGA has changed the way of regulating custom-made medical devices in Australia, and the changes affect anyone who is manufacturing, importing, or supplying custom-made medical devices, including healthcare providers.
According to the Therapeutic Goods (Medical Devices) Regulations, 2002, a custom-made medical device is defined in the following terms: