Guidance
IVD medical devices — classification + conformity assessment
IVD classification (Class 1-4) + conformity assessment requirements.
In plain English
This guidance explains how to classify IVD medical devices and what conformity assessments are needed.
The Therapeutic Goods Administration (TGA) provides this guidance. It applies to manufacturers, importers, and suppliers of in-vitro diagnostic medical devices. It outlines the classification of IVDs (Class 1 to 4). It details conformity assessment requirements for each class. The guidance is current as of the date of the webpage.
Why it matters
If you manufacture, import, or supply IVDs, understand this guidance. Correct classification and conformity assessment are essential for legal compliance. Failure to do so can impact your business’s ability to operate.
AI-assisted summary, grounded in the source link below. Generated 2026-05-23 via gemma3:12b.
Issuing regulator
TGA →Topics
Source: https://www.tga.gov.au/products/medical-devices/in-vitro-diagnostic-medical-devices-ivds. Rules Mate indexes + summarises; always verify against the regulator's live publication.