Summary
Explains when AI or software is regulated as a medical device in Australia and how intended purpose, risk classification, evidence, conformity assessment, Australian Register of Therapeutic Goods inclusion, and lifecycle obligations apply.
Healthcare Implications
Manufacturers and sponsors should determine whether AI functions meet the medical-device definition, assign the correct classification, and meet Essential Principles, quality, clinical-evidence, cybersecurity, change-control, and post-market obligations. Health providers should verify regulatory status and evidence before procurement and deployment.