Post-Market Obligations Overview: Where the Sponsor’s 10 Ongoing Responsibilities Come From

1. Key takeaways

For sponsors in the Australian market, post-market obligations are a chain of duties that takes effect automatically. The core of that chain sits in section 41FN of the Therapeutic Goods Act 1989 — the so-called “automatic conditions” — read together with the reporting and record-keeping clauses of the Therapeutic Goods (Medical Devices) Regulations 2002. The TGA has officially consolidated these duties into 10 ongoing responsibilities, and the consequences of failing any of them are material: suspension or cancellation of the ARTG entry, infringement notices, and exposure to criminal or civil liability. None of these duties depends on a warning from the regulator to become binding; they attach to the inclusion in the ARTG by operation of law, and every item remains enforceable for as long as the entry is in place. The 10 items span both technical and administrative ground: some demand regulatory judgement, such as reporting adverse events or implementing market actions, while others — paying annual charges, keeping eBusiness contact details current, and notifying the TGA that a manufacturer’s certificate has ceased to be valid — are purely administrative steps. A sponsor that manages the technical duties well can still end up with an abnormal entry status if the administrative items are left unattended, which is why this guide treats the two groups with equal weight.

2. Legal basis

The instruments and provisions below form the legal basis of the sponsor’s ongoing duties. Citations follow the official documents, and the compiled regulation version current at the time of verification is noted where applicable. The Act, the Regulations and the TGA guidance pages should be read together: the Act sets the automatic conditions, the Regulations supply the detailed reporting mechanics, and the guidance consolidates both into the 10-item list used in day-to-day compliance management.

1. Official TGA summary (Understanding your post-market responsibilities for medical devices, page published 1 April 2022, current version 12 March 2026): the ongoing obligations total 10 — complying with additional conditions; complying with automatic conditions; reporting adverse events; implementing market actions; applying for consent in respect of non-compliance with the Essential Principles; notifying the TGA that a manufacturer’s certificate of conformity has ceased to be valid; complying with advertising requirements; reporting suspected counterfeit or tampered devices; paying annual charges; and keeping eBusiness contact details up to date.
2. Automatic conditions: Therapeutic Goods Act 1989 (Act No. 21, 1990), section 41FN — 41FN(1) entry to and inspection of premises; 41FN(2) supplying samples on request; 41FN(3) availability of information, including 41FN(3)(d) on the reporting of particular events and performance issues; and 41FN(5) on advertising materials.
3. Adverse event reporting: Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compiled version F2026C00883), Part 5, Division 5.2, clause 5.7, operating together with section 41FN(3)(d) of the Act.
4. Corrective actions and market actions: section 41KA of the Therapeutic Goods Act 1989.
5. The manufacturer’s evidence obligation: section 41FN(3) — manufacturers must hold, at all times, evidence demonstrating compliance with the Essential Principles.

3. Expert insights

Insight 1: three of the 10 obligations are financial or informational in nature, and they are the easiest to overlook. Paying annual charges, keeping eBusiness contact details current, and notifying the TGA that a manufacturer’s certificate of conformity has become invalid involve no technical judgement whatsoever — yet these three items are among the most frequent causes of an abnormal entry status. They are purely administrative actions, which makes them well suited to calendar-based management rather than to attention that arrives only when a problem has already surfaced. In practice we place all three on a fixed annual cycle with a named owner, so that whether a duty was performed never depends on memory or on individual staff movements.

Insight 2: reporting suspected counterfeit or tampered devices is a standalone obligation. It does not sit anywhere inside the adverse event sequence; it is a separate ongoing responsibility in its own right. Where suspected tampering emerges anywhere in the supply chain, the applicable route is the 24-hour notification channel (see article 44 for the details of that timeline). The separation matters operationally: the two channels run on different clocks and different triggers, and routing tampering suspicions through the adverse event workflow risks losing the 24-hour discipline that this standalone duty demands.

Insight 3: the consequences of non-compliance are tiered. They escalate from infringement notices and additional conditions, through suspension and cancellation of the entry, up to criminal and civil liability, with the intensity of the response increasing at each step. Article 47 of this guide expands on this escalation ladder and on what each rung means in practice for the sponsor. Because the rungs are sequential, the stage a sponsor finds itself in also indicates what kind of response — and what kind of evidence — is available at that point.

4. Practical recommendations

• Convert the 10 ongoing responsibilities into an annual compliance calendar, recording for each item its trigger condition, deadline, responsible owner, and the method by which evidence of performance will be retained.
• Configure annual charges and eBusiness contact updates as fixed annual actions; configure notification of a manufacturer’s certificate becoming invalid as an event-driven action that fires the moment the facts occur.
• Establish a dedicated reporting channel for suspected counterfeit or tampered devices, running in parallel with — but kept clearly separate from — the adverse event reporting channel.
• Carry out at least one self-audit of obligation performance each year, and retain the audit records as compliance evidence that can be produced to the TGA or to an auditor on request.

5. Verification checklist

• □ All 10 ongoing responsibilities have been mapped to internal actions
• □ Each subsection of the automatic conditions in section 41FN has been built into the performance checklist
• □ Annual charges and contact-detail updates are configured as fixed annual actions
• □ A separate reporting channel for suspected counterfeit or tampered devices has been established
• □ The annual self-audit has been completed and its records retained

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team manages adverse event reporting and recall coordination with the TGA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com