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.
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.