Application for priority applicant determination - medical devices

To apply for a priority applicant determination for your medical device(s), you must complete and submit this form along with sufficient supporting information addressing the relevant eligibility criteria.

Before submitting your application, refer to the 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.

Application form