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Priority applicant guidelines for medical devices (including IVDs)
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
- 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
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