Overview & Ongoing Responsibilities
Overview
ARTG inclusion is not the end of regulatory obligations — it is the beginning of an ongoing relationship between the sponsor, manufacturer, and the TGA. Post-market obligations are a condition of ARTG inclusion and apply for as long as the device is supplied in Australia. Breaching post-market obligations can result in ARTG suspension or cancellation, financial penalties, and in serious cases criminal prosecution.
The post-market regulatory framework reflects a simple principle: the TGA cannot assess every device exhaustively before it reaches the market, so it relies on manufacturers and sponsors to actively monitor performance and report problems. This places genuine responsibility on industry.
Who Has Post-Market Obligations
Sponsors are the primary regulatory contact in Australia. Their post-market obligations include:
- Reporting adverse events and near adverse events to the TGA via IRIS
- Managing recalls and field safety corrective actions under PRAC
- Maintaining distribution records sufficient to enable effective recalls
- Keeping manufacturer conformity assessment evidence current
- Notifying TGA of significant device changes
- Paying annual ARTG charges
- Ensuring labelling and advertising remain compliant
- Providing information to the TGA when requested within required timeframes
Manufacturers have their own ongoing obligations:
- Monitoring device performance through post-market surveillance
- Investigating adverse events and complaints
- Updating technical documentation when the device changes
- Notifying sponsors of any safety issues, changes, or overseas regulatory actions
- Maintaining a compliant quality management system
The Five Key Post-Market Obligations
| Obligation | Who | Key timeframe |
|---|---|---|
| Adverse event reporting | Sponsor | 2–48 hours to 30 days depending on severity |
| Recalls & field safety actions | Sponsor | Immediate notification to TGA; strategy approval before action |
| Post-market surveillance | Manufacturer | Ongoing; annual reports for some device classes |
| ARTG maintenance | Sponsor | Ongoing; notify TGA of changes; pay annual charges |
| Labelling & advertising compliance | Sponsor & manufacturer | Ongoing; no advertising without ARTG basis |
Recent Changes Affecting Post-Market Compliance
Two significant changes have affected post-market obligations recently:
1. PRAC (March 2025) The Procedure for Recalls, Product Alerts and Product Corrections (PRAC) replaced the Uniform Recall Procedure for Therapeutic Goods (URPTG) from 5 March 2025. The PRAC simplifies recall terminology and reduces the number of procedural steps from 10 to 5.
2. Mandatory Adverse Event Reporting by Healthcare Facilities (March 2025 onwards) From 21 March 2025 a 12-month voluntary reporting period commenced for healthcare facilities. From 21 March 2026, healthcare facilities must mandatorily report adverse events involving high-risk devices. This expands the reporting ecosystem beyond sponsors — sponsors should be aware that adverse events may now be reported by hospitals directly to the TGA, and should ensure their own investigation processes are robust.
Official Sources
- Understanding post-market responsibilities — TGA
- Post-market overview — TGA
- Part 4-9 — Therapeutic Goods Act 1989 (post-market obligations)