MedTech
Is it a medical device or a wellness app? The TGA decides, based on what you say it does.
Book a MedTech evidence review.
Contact usMedTech in Australia spans medical devices, implantables, wearables, consumer health apps and Software as a Medical Device (SaMD). The TGA classifies based on intended purpose: diagnosing, monitoring, treating, preventing or alleviating a condition. The moment your app or device claims any of those, it is a medical device and needs ARTG inclusion. Stay clearly in wellness and the ACCC governs claims under the Australian Consumer Law. Parallaxis helps founders decide which side of the line to sit on, and builds evidence designed to clear both the TGA and the FDA where the commercial endgame requires it.
The Regulatory Landscape
Software with a medical purpose is a medical device. The TGA applies specific SaMD classification rules covering diagnosis, monitoring, treatment recommendations and clinical decision support.
The three US pathways for medical devices. 510(k) clearance is for devices substantially equivalent to a marketed predicate. De Novo is for novel low-to-moderate risk devices without a predicate, and can itself become a predicate for future 510(k) submissions. Pre-Market Approval is the highest bar, required for Class III high-risk devices. Each pathway carries different evidence requirements, timelines and cost.
Most MedTech founders will need both. Evidence built only for the TGA can require costly rework to support a future 510(k) or De Novo. Designed properly from the start, the same evidence base supports both.
Where Companies Get Stuck
Claiming too much too early and accidentally becoming a medical device.
TGA evidence that does not transfer to a US filing because it was not designed to.
Technical files, clinical evaluation reports and post-market surveillance plans retrofitted after launch.
The Proof We Build
- Intended purpose statement and classification position.
- Clinical evidence strategy designed for TGA and FDA in parallel where relevant.
- Claims architecture across clinical, professional and consumer channels.
- Investor-ready evidence package for fundraising and diligence.
Common Questions
The deciding question is what the app does, not what it tracks. If it diagnoses, monitors a specific disease, or recommends treatment, it is a medical device. If it supports general wellness without clinical claims, it sits outside the TGA framework.
Sometimes, if the trial and technical file were designed with FDA expectations in mind. FDA standards are often more demanding. Evidence built only for ARTG inclusion often needs rework to support a 510(k) or De Novo.