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'.
contents
About these guidelines
The two types of priority applicant determinations
Legislative framework
Criteria for priority applicant determination
Addressing the criteria
The application process
The TGA assessment process
Case studies
Flowchart of the priority applicant determination process
