Therapeutic Goods Administration on Personalised Medical Devices

Most personalised allied health medical devices, such as hand splints and compression garments, are low risk, particularly when they are used in treatment by trained professionals. It is important to protect patients and clinicians but there is no need to duplicate time and effort already being spent on existing quality assurance processes outside TGA regulation. For most of the personalised medical devices relevant to allied health, AHPA therefore supports exemption from registration rather than exclusion from all TGA requirements.