TGA October 2026 Update to Ventilator, CPAP and BiPAP Foam Review Lists: PE-PUR Cases Finalised, Other Foam Types Still Under Assessment

On 9 October 2026, the Australian Therapeutic Goods Administration (TGA) updated its public lists under the post-market review of ventilator, continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) devices. The review was triggered by risks identified in polyester-based polyurethane (PE-PUR) sound-abatement foam used in Philips-related products. According to the TGA, devices from non-Philips sponsors that contain PE-PUR foam in the breathing gas pathway have now been finalised on a device-by-device basis, with outcomes including cancellation of ARTG registrations and various market actions, while devices containing other types of foam in the breathing gas pathway remain under evaluation. Where evidence is insufficient, the TGA has applied a Condition of Inclusion (COI) to the ARTG registration, requiring the sponsor to provide long-term safety evidence. The TGA has also commenced Federal Court proceedings against Philips Australia for alleged non-compliant supply and has issued ten infringement notices.

What the TGA Updated in October 2026

On 9 October 2026, the TGA updated its public lists for the post-market review of ventilator, CPAP and BiPAP devices. The update appeared in the TGA What's new listing, and the page updated was the List of ventilator, CPAP and BiPAP devices containing other types of foam material (not PE-PUR foam) in the breathing gas pathway. The review overview page also states that this post-market review, covering all ventilators, CPAP and BiPAP devices included in the Australian Register of Therapeutic Goods (ARTG), is nearing completion.

Origin of the Review

The review was initiated after risks were identified in polyester-based polyurethane (PE-PUR) foam used for sound abatement in Philips-related products. The TGA subsequently expanded the scope to all comparable devices on the ARTG: continuous and non-continuous ventilators, emergency ventilators, portable ventilators, CPAP and BiPAP devices. In each case, the TGA sought to confirm whether sound-abatement foam is present in the breathing gas pathway and whether that foam presents a health risk. The approach was not a blanket withdrawal from the market. Instead, sponsors were required to submit device-specific evidence supporting long-term safety, on the basis of which the TGA made its decisions.

Two Foam Categories at Different Stages

Under the TGA classification, two groups of devices must be considered separately.

• Devices containing PE-PUR foam in the breathing gas pathway that are not supplied by Philips: the TGA states that it has verified evidence with all sponsors and reached a final decision for each device, with outcomes including cancellation of ARTG registration and various market actions.
• Devices containing other types of foam (not PE-PUR) in the breathing gas pathway: these remain under assessment. Where evidence is insufficient, the TGA applies a Condition of Inclusion (COI) to the ARTG registration, requiring the sponsor to supplement the evidence supporting long-term safety. Details of any COI can be found on the device's ARTG certificate.

Specific Outcomes Visible in the Lists

The public lists show several typical outcomes.

• Some sponsors submitted sufficient additional evidence, the review was closed and the previous COI was removed. Examples include the Lowenstein Medical prisma and VENT series; Hamilton Medical devices T1A, C1A, MR1A, C3A and C6A supplied by Device Technologies Australia; and several home CPAP/BPAP devices from BMC Medical supplied through Emergo Australia.
• Some devices are no longer supplied and their ARTG registrations have been cancelled by the sponsor, such as the Compumedics Somnilink SPAP and the Breas isleep20 series.
• Others remain under review: Drive Devilbiss DV64E-UK has been asked to provide further information, and the ARTG registrations for Breas VIVO 1/2/3 currently carry a COI.

Enforcement Action Against Philips

The overview page also records actions taken by the TGA against Philips Australia. The TGA has commenced proceedings in the Federal Court of Australia against Philips Australia Pty Ltd over the alleged supply of medical devices that do not meet Australian safety and performance requirements. In addition, the TGA issued ten infringement notices because the company failed to provide information within the statutory timeframe regarding performance degradation in certain ventilator, CPAP and BiPAP devices. COIs previously applied to the ARTG registrations of the affected devices have been removed following the company's corrective actions.

What Companies Should Do Next

For companies supplying respiratory devices to Australia, the message from these lists is direct: whether sound-abatement foam is present in the breathing gas pathway, what material the foam is, and whether it sits inside or outside the gas pathway all affect the review outcome and the registration status. The argument that a material is common and has been used in the industry for years is not sufficient to pass review; long-term safety evidence is the decisive factor in whether a COI is lifted and whether registration is retained. Companies that have already received a COI should treat the supplementary evidence submission as a time-bound compliance task and should also assess whether instructions for use, risk assessment documentation and customer communication materials need updating. Companies that have not yet received an inquiry should proactively map the gas pathway materials in their own products to avoid a reactive response in later rounds.

Sources and Scope of Verification

• Therapeutic Goods Administration (TGA) - Post-market review of ventilator, CPAP and BiPAP devices (review overview page).
• Therapeutic Goods Administration (TGA) - List of ventilator, CPAP and BiPAP devices containing other types of foam material (not PE-PUR foam) in the breathing gas pathway; this page appeared in the TGA What's new listing on 9 October 2026.
• Therapeutic Goods Administration (TGA) - List of ventilator, CPAP and BiPAP devices containing PE-PUR foam material in the breathing gas pathway.
• Therapeutic Goods Administration (TGA) - What's new (entry dated 9 October 2026).

Verification scope and date of access: this verification accessed the above official TGA pages on 15 October 2026 to check the post-market review overview, the conclusions stated in the two foam lists, and the date of the What's new entry. No company or product information beyond the official pages has been added.

Scope note: this article is an interpretation of publicly available regulatory information. It does not constitute a conclusion or commitment regarding any specific product, company or registration application, nor does it represent a regulatory authority's determination on any company's product. The official text prevails in all respects, and information may change with subsequent official updates.

AIMEILI Regulatory Interpretation

The October 2026 update confirms that the TGA is treating the foam issue as a materials-in-the-gas-pathway question rather than a single-manufacturer problem. The key regulatory variable is not the company name but the position of the foam relative to the breathing gas pathway and the availability of long-term safety evidence. For PE-PUR foam in non-Philips devices, the TGA has completed its device-by-device assessment and delivered final outcomes, including ARTG cancellations. For all other foam materials in the breathing gas pathway, the review remains open, and the TGA is using the Condition of Inclusion as its standard interim control mechanism. A COI is not a suspension, but it is a formal restriction recorded on the ARTG certificate, and it obliges the sponsor to close the evidence gap within the timeframe set by the TGA. The removal of COIs for Lowenstein Medical, Hamilton Medical and BMC Medical devices shows that the pathway to a clean registration status exists, but it requires sponsor-supplied evidence rather than reliance on general material history. The Federal Court proceedings and the ten infringement notices against Philips Australia reinforce that non-compliance with statutory information requests is itself an enforcement exposure, separate from the product safety assessment. Companies should also note that the review overview page indicates the overall review is nearing completion, which means remaining COIs and unresolved device assessments are likely to be addressed in the near term rather than left open indefinitely.

Business Impact

For manufacturers, distributors, CROs and regulatory affairs teams, the practical consequences are threefold.

• Registration continuity: ARTG registrations for respiratory devices can be affected by foam material composition and placement. Devices with an active COI may face restrictions on supply, tender participation or hospital procurement in Australia until the condition is lifted.
• Evidence burden: Sponsors must be able to demonstrate long-term safety of foam materials in the breathing gas pathway, including material characterisation, ageing or degradation data, particulate and volatile organic compound testing where relevant, and a documented risk assessment. Generic claims of established industry use are unlikely to satisfy the TGA.
• Dossier and labelling alignment: Risk management files, instructions for use, cleaning and maintenance instructions, and field safety communications may need updating to reflect the TGA's current position. Distributors and CROs supporting Australian registrations should align their technical documentation with the revised evidence expectations.
• Timing and cost planning: Where a COI is in place, sponsors should build the evidence submission into a defined compliance timeline and budget for testing and documentation updates. Where no inquiry has yet been received, an internal gas pathway materials review is a low-cost way to avoid a reactive and compressed response in a later TGA round.
• Enforcement awareness: The action against Philips Australia, including the infringement notices for late provision of performance degradation information, highlights that failure to respond to TGA information requests within statutory deadlines carries independent enforcement risk.

Companies supplying respiratory devices to Australia should treat the foam review as an ongoing compliance programme rather than a one-off event, and should monitor the TGA What's new page and the review lists for further updates as the review concludes.