In-vitro diagnostic medical device classification + ARTG
IVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
Who must comply
IVD manufacturers + sponsors.
What triggers it
Manufacturing or sponsoring IVDs in Australia.
When due
Continuous; periodic conformity reassessment.
Evidence required
ARTG inclusion; conformity assessment certificate; technical file.
Max penalty
Civil + criminal penalties; ARTG cancellation
Summary
Therapeutic Goods (Medical Devices) Regulations 2002 + IVD classification framework (Class 1 lowest risk through Class 4 highest). All IVDs require ARTG inclusion + conformity assessment per class.
Enforced by
Source legislation
Industries
Topics
Source: https://tga.gov.au/products/medical-devices/manufacturing-medical-devices/in-vitro-diagnostic-medical-devices. Rules Mate is not a law firm. Always verify against the live regulator source before acting.