About personalised medical devices
Personalised medical devices are made or adapted for individual patients. Examples include prostheses, dentures and aligners, and implants tailored to a specific patient.
Personalised medical devices fall into one of 3 categories:
- adaptable medical devices are personalised after they are manufactured
- patient-matched medical devices are personalised before they are manufactured
- custom-made medical devices are designed and manufactured for an individual, but only in rare and exceptional cases where no other alternative exists.
Each of these categories has different regulatory requirements.
You are responsible for ensuring personalised devices meet quality, safety and performance standards.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to personalised medical devices. You may also have to meet obligations that apply to all medical devices and all products.
