We accept different kinds of regulatory evidence for medical devices. One option is a TGA issued conformity assessment certificate.
Guidance
Prepare your application by reading Application instructions: Conformity assessment certification.
Forms
Following an application, we will send an acknowledgement email requesting supporting data.
You must submit the 'Supporting data form' with your application supporting data. Forms must be current and complete.
Use either the Word or PDF version of the form with additional form pages as needed (e.g., for several facilities, devices, etc.).
Additional pages
See below for additional pages.