Overview & Process
How to apply for ARTG inclusion for a medical device in Australia — the steps, what preliminary assessment involves, and key things to get right.
By Device Class
How the ARTG inclusion process and requirements differ by device class — from Class I self-certification through to Class III full assessment.
Application Audits
How TGA application audits work, which applications are selected for mandatory audit, and how to prepare for and respond to an audit request.
Fees & Charges
TGA application fees and annual charges for medical device ARTG inclusion — what is charged, when it is payable, and where to find current fee schedules.
Conditions of Inclusion
The ongoing conditions that sponsors and manufacturers must comply with as a condition of a device's ARTG inclusion in Australia.