Start with what is tested and how results are used
An IVD project should identify the analyte, specimen type, testing purpose, target population and use setting, such as professional use or self-testing. The same testing technology may have different risk classifications when used for different purposes.
IVDs follow separate classification rules
Australian IVDs use Class 1 to Class 4, rather than non-IVD Class I, IIa, IIb and III. Classification considers intended use and risks of incorrect results to individuals and public health.
Review product documentation alongside performance evidence
Assess technical files, performance evidence, labels, IFU and quality systems against applicable requirements, then plan manufacturer evidence, Sponsor arrangements and application tasks.
Frequently asked questions
How do professional-use and self-test versions differ for registration?
Self-testing and professional use affect intended purpose, users and evidence needs; changing the wording of professional instructions does not establish suitability for home use. Clarify who collects the sample, runs the test and interprets results, and their training. Classification also depends on the test purpose and the risks of incorrect results. Review labels, instructions and workflows for each version against the intended setting and supporting evidence.
Official sources:TGA — Classifying IVD medical devices for supply in Australia
Checked:
What should an IVD registration brief include beyond the reagent name?
Start an IVD assessment with the analyte, specimen type, intended purpose, users, result interpretation and associated instruments, then assess classification and performance evidence needs. A catalogue alone may not define the full scope. Map reagents, calibrators, controls, software and instruments, identifying manufacturers and separate supply. Organizing information around the actual testing workflow helps distinguish reusable documentation from products or use settings needing separate assessment.
Official references
- TGA — Classifying IVD medical devices for supply in Australia
- TGA: steps to supply medical devices for Sponsors
Sources checked: 2026-09-11. Assess individual products and projects against current applicable requirements.
