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 (up to $1.69M / $16.9M); ARTG cancellation
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
Source: https://tga.gov.au/safety/safety-monitoring. Rules Mate is not a law firm. Always verify against the live regulator source before acting.