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Priority applicant guidelines for medical devices (including IVDs)

Priority applicant determination criteria and process
2 December 2020
Download 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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