Conduct post-market surveillance of therapeutic goods
ARTG-included goods must be monitored post-market for safety + performance.
Who must comply
ARTG sponsors + manufacturers (medicines + devices + biologicals).
What triggers it
Inclusion of goods in the ARTG.
When due
Continuous; adverse-event reports per timeframes; periodic safety updates.
Evidence required
PMS plan; adverse-event register; safety updates; recall procedure.
Max penalty
Civil + criminal penalties (civil up to $1.82M individual / $18.2M body corporate); ARTG cancellation
Who must comply with this? The applicability test by industry, business structure and size.
Summary
Part 5-1 Therapeutic Goods Act + ARTG conditions require sponsors to conduct post-market surveillance — adverse-event reporting, safety updates, recall when warranted. Medical-device manufacturers operate quality management systems aligned to ISO 13485 with TGA conformity assessment.
Enforced by
Source legislation
Industries
Topics
Related
- CWLTHIn-vitro diagnostic medical device classification + ARTGIVDs classified by risk (Class 1-4); ARTG inclusion required for supply.
- CWLTHMaintain controlled drugs register (Schedule 8 / 9)Pharmacies + medical practices must keep contemporaneous register of S8/S9 medicines.
- CWLTHMaintain PBS approval + claim accurately for PBS-listed medicinesPharmacy approval-to-supply under s 90 National Health Act; PBS claiming subject to compliance review.
- CWLTHComply with the Therapeutic Goods Advertising CodeAdvertising of therapeutic goods to consumers must comply with the TGA Advertising Code and prohibited representations.
Reading
Frequently asked questions
- Who must comply with post-market surveillance of therapeutic goods?
- ARTG sponsors + manufacturers (medicines + devices + biologicals).
- What triggers post-market surveillance of therapeutic goods?
- Inclusion of goods in the ARTG.
- When is post-market surveillance of therapeutic goods due?
- Continuous; adverse-event reports per timeframes; periodic safety updates.
- What is the maximum penalty for post-market surveillance of therapeutic goods?
- Civil + criminal penalties (civil up to $1.82M individual / $18.2M body corporate); ARTG cancellation
- What evidence is required for post-market surveillance of therapeutic goods?
- PMS plan; adverse-event register; safety updates; recall procedure.
Source: https://www.tga.gov.au/safety. Rules Mate is not a law firm. Always verify against the live regulator source before acting.