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
Related obligations
- CWLTHConduct post-market surveillance of therapeutic goodsARTG-included goods must be monitored post-market for safety + performance.
- CWLTHMaintain PBS approval + claim accurately for PBS-listed medicinesPharmacy approval-to-supply under s 90 National Health Act; PBS claiming subject to compliance review.
- CWLTHMaintain controlled drugs register (Schedule 8 / 9)Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.
- CWLTHComply with the Therapeutic Goods Advertising CodeAdvertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.
Frequently asked questions
- Who must comply with In-vitro diagnostic medical device classification + ARTG?
- IVD manufacturers + sponsors.
- What triggers In-vitro diagnostic medical device classification + ARTG?
- Manufacturing or sponsoring IVDs in Australia.
- When is In-vitro diagnostic medical device classification + ARTG due?
- Continuous; periodic conformity reassessment.
- What is the maximum penalty for In-vitro diagnostic medical device classification + ARTG?
- Civil + criminal penalties; ARTG cancellation
- What evidence is required for In-vitro diagnostic medical device classification + ARTG?
- ARTG inclusion; conformity assessment certificate; technical file.
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.