Medical Device Regulatory Support & TGA Inclusion
The Problem
Medical devices in Australia require TGA inclusion on the Australian Register of Therapeutic Goods (ARTG). The classification system, essential principles, and documentation requirements can overwhelm teams without dedicated regulatory expertise - especially for software as a medical device (SaMD) or novel technologies..
What We Do
HealthREG provides end-to-end support for medical device sponsors, from initial classification and conformity assessment to ARTG inclusion and post-market surveillance. We work with Class I through Class III devices, including IVDs and SaMD.
Who this is for
Medtech start-ups with first-time TGA submissions
International device manufacturers entering Australia
Established sponsors managing multiple device portfolios
Product developers needing regulatory input during design
Why HealthREG?