SaMD
Software as a medical device in Australia.
Digital health products can become regulated medical devices when their intended purpose involves diagnosis, prevention, prediction, monitoring, treatment, or clinical decision support. Early classification work is essential.
Why software needs early planning
Software products change quickly. New features, algorithms, integrations, and claims can alter regulatory status or classification. A product that appears low-risk commercially may still need evidence for safety, performance, cybersecurity, usability, clinical validation, and lifecycle change control.
Key questions for SaMD teams
- What is the intended medical purpose of the software?
- Who uses it: patient, clinician, administrator, or another system?
- Does it inform, recommend, diagnose, monitor, or drive treatment?
- What evidence supports clinical performance and risk controls?
- How are updates, bugs, cybersecurity issues, and model changes controlled?
- Are website, app store, and sales claims aligned with the intended purpose?
How Ocevia helps
Ocevia supports SaMD and digital health teams with classification review, pathway planning, evidence gap analysis, documentation review, labelling and claims review, and post-market change management planning for Australia.