What to do when the TGA knocks again: proposal to suspend or cancel

The call comes from your regulatory affairs team: the Therapeutic Goods Administration (TGA) has finished its investigation into your medical device and issued a proposal to suspend or cancel it from the Australian Register of Therapeutic Goods (ARTG). The stakes have escalated. What now?

This is the second article in our series examining the processes for suspending or cancelling medical devices from the ARTG. Our first article, which looked at the TGA’s investigative and information-gathering powers, is here.

This article explains what happens when the TGA proposes to suspend or cancel a medical device from the ARTG, and provides practical guidance on how sponsors should best respond.

The TGA’s suspension powers

A suspension deems a medical device not to be included in the ARTG. This means the device cannot be imported, exported, manufactured or supplied in Australia while suspended.[1] Suspension gives sponsors a window to address identified deficiencies before cancellation. But if those deficiencies remain unresolved when the suspension period expires, cancellation follows automatically.[2]

Under the Therapeutic Goods Act 1989 (Cth), the TGA may suspend a device from the ARTG if satisfied that:

• there is a potential risk of death, serious illness or serious injury, and remedial action can likely be taken within the suspension period;[3] or
• it is likely that there are grounds for cancelling entry of the device from the ARTG.[4] We discuss these grounds further below.

Importantly, before suspending an ARTG entry, the TGA must:[5]

• provide written notice of the proposed suspension, including the reasons for it, to the sponsor; and
• give the sponsor a reasonable opportunity to make submissions in relation to the proposed suspension.

The TGA cannot suspend an ARTG registration until it has considered any submissions made by the sponsor. However, these procedural requirements do not apply where suspension is proposed on the basis of a potential risk of death, serious illness or serious injury.[6] In those cases, suspension may take effect immediately.[7]

The TGA’s cancellation powers

Cancellation of an ARTG entry means the device cannot be imported, exported, manufactured or supplied in Australia indefinitely, unless otherwise exempt or approved.

The TGA may cancel the ARTG entry if one or more of the following are established:[8]

• the medical device has changed
• the sponsor fails to comply with a condition of ARTG inclusion (e.g. failure to comply with the Essential Principles)
• the sponsor fails to comply with a section 41JA notice (as discussed in our first article)
• the sponsor contravenes adverse event reporting obligations
• the safety or performance of the device is unacceptable
• a certification is incorrect in a material particular
• a conformity assessment document or overseas regulator document has expired or been revoked
• the sponsor contravenes an advertising direction
• the sponsor breaches advertising provisions of the Therapeutic Goods Advertising Code, TG Act or Therapeutic Goods Regulations.

Similar to the suspension process, before making a final decision to cancel an ARTG registration, the TGA must: [9]

• provide written notice of the proposed cancellation, including the reasons for it, to the sponsor; and
• give the sponsor a reasonable opportunity to make submissions in relation to the proposed cancellation.

The TGA cannot proceed with cancellation until it has considered any submissions.[10] However, the TGA may immediately cancel an ARTG entry if:[11]

• it poses an imminent risk of death, serious illness or serious injury
• it is no longer a therapeutic good or medical device
• the sponsor requests cancellation
• a statement in an application for ARTG entry or a certification is false or misleading
• the annual charges are not paid
• the sponsor contravenes an advertising direction, and the contravention is significant
• the sponsor breaches advertising provisions of the Therapeutic Goods Advertising Code, TG Act or Therapeutic Goods Regulations, and the breach is

Cancellation on any of the above grounds may take effect immediately, on the day written notice is given to the sponsor.[12]

Finally, as noted above, an ARTG entry is automatically cancelled if it remains suspended when the suspension period expires.

Responding to proposals: requirements

No minimum response period applies. Instead, a ‘reasonable opportunity’ to make submissions must be provided, with a deadline specified in the proposal. Extensions can be requested, but are granted at the TGA's discretion.

Critically, the TGA will typically treat the sponsor’s first submission as the complete and final response. This makes it essential to provide a single, comprehensive submission that addresses all identified deficiencies with supporting evidence.

Responding to proposals: practical guidance

1. Take the proposal seriously and act quickly: Escalate the proposal to internal and external legal advisers to fast-track the strategy for the response.
2. Prepare a single, comprehensive submission: Given the TGA’s practice of deeming the first submission as the complete and final response, it is essential that this initial submission is comprehensive and addresses every identified deficiency in full.
3. Show steps taken to address deficiencies: The submission should clearly set out the actions that have been taken, those currently underway, and those proposed to address each identified deficiency and achieve compliance. Each action should be supported by detailed technical and clinical evidence.
4. Seek an extension early: If more time is required, approach the TGA well before the deadline with clear reasons as to why more time is required, steps that have already been taken to comply, and a date by which a complete submission can be provided. Any extension will be a matter for the TGA’s discretion, and sponsors should not assume that requests will be granted.
5. Handling trade secrets and clinical data: Where a submission contains commercially sensitive material, label those parts “Confidential—commercial‑in‑confidence” and request that they be treated confidentially. In some circumstances, it may be appropriate to include language relating to FOI requests that may be made by third parties, which could catch confidential information in correspondence with the TGA.
6. Plan ahead: Begin contingency planning for a potential escalation, and begin preparations to pursue any available review pathways.

Concluding remarks

A proposal to suspend or cancel an ARTG entry carries significant legal and commercial risks. But remember: a proposal is not a final decision.

A well-prepared submission that clearly addresses all identified deficiencies can persuade the TGA not to proceed.  Sponsors who follow this approach  increase the prospects of avoiding the TGA proceeding to reach a final decision.

Our next article will look at the avenues for review that may be available to you if the TGA does ultimately proceed.