The purpose of these guidelines is to assist applicants seeking a conformity assessment (priority applicant) determination or a medical devices (priority applicant) determination. These guidelines generally refer to such determinations, in either case, as 'priority applicant determinations'.
About these guidelines
The two types of priority applicant determinations
Criteria for priority applicant determination
Addressing the criteria
The application process
The TGA assessment process
Flowchart of the priority applicant determination process
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.