Application for medical device priority applicant determination

This is an application for either a Conformity Assessment (priority applicant) determination OR a medical devices (priority applicant) determination.

Guidance

Prepare your application by reading Priority applicant guidelines for medical devices (including IVDs). 

These guidelines outline the application process, the criteria your device must meet to be eligible for priority applicant determination, and how to pay your application fee.

Submitting your form

Email your form to PriorityDevices@health.gov.au with the subject: Pre-submission meeting request - priority applicant determination for (name of medical device or IVD).