TGA Guidance for AI Screening Kiosk

I have developed an AI-driven, contact-less oral-health screening kiosk and now need to secure formal approval from the Therapeutic Goods Administration and obtain an ARTG listing. The device combines hardware, imaging sensors and embedded software (SaMD) to assess oral conditions without a clinician present, so the regulatory path is more complex than a standard medical device submission.

My immediate goal is to move from a functioning prototype to full market release in Australia, which means:
• mapping the correct TGA route for a Class I/IIa device with software,
• closing any technical or clinical evidence gaps,
• preparing the complete dossier and e-submission package, and
• finalising the ARTG listing.

I can supply all existing design files, risk-management documentation (ISO 14971), software lifecycle paperwork (IEC 62304) and preliminary clinical performance data; what I need is an experienced consultant who can turn these raw materials into a compliant, audit-ready submission and guide me through each regulator interaction until the ARTG entry number is issued.

If you have recent, hands-on success with digital diagnostic devices or SaMD in Australia, I’d like to hear how you would structure the project timeline, anticipated milestones and any additional testing or documentation you expect we’ll need.