September 14th – 18th 2026
Inform Items
- eIFUs – Following discussion at the RegTech meeting on 8 September, attached are proposed amendments to Essential Principle 13 regarding the provision of instructions for use for medical devices. If you have any concerns, please contact devicereforms@tga.gov.au by Friday, 25 September.
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MTAA RegConnect Summit 2026 – With the Summit just a week away (24–25 September, ICC Sydney), the full two-day program is now live. Highlights include international regulators from the MHRA, European Commission, US FDA, HSA Singapore and Health Canada on IMDRF priorities, priority pathways and EU MDR, sessions on post-market surveillance and UDI in practice, the Association of Medical Device Reprocessors on the future of circular MedTech and Scarlet on certifying AI and SaMD, the MTAA Regulatory Excellence Awards, and a not-to-miss closing session where TGA representatives take attendees’ most-upvoted questions live on stage.
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Medical Devices Regulations Amendments Registered – Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 introduce a new classification rule (Clause 2.2, Part 2, Schedule 2) for non-invasive devices used to maintain patency or flush the lumen of another device, such as pre-filled saline flush syringes and vascular access device locking solutions, now classified as Class IIa where the intended purpose is patency maintenance or flushing and the device contains only saline (products with ancillary medicinal substances such as anticoagulants, antibiotics or antihistamines remain Class III under Rule 5.1). The new rules apply to ARTG applications from 7 September 2026, with a five-year transition period for existing entries and prior applications. The same amendments also clarify when clinical decision support software (CDSS) exemptions apply. Sponsors of affected products should review their ARTG entries against the new criteria and transition arrangements. Further detail on the TGA website: combination products classification and CDSS exemption amendments.
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New TGA Guidance on News and Advertising Rules – Following earlier consultation, the TGA will soon publish guidance (attached) titled “Determining when news is subject to the therapeutic goods advertising rules,” helping journalists and news organisations report on therapeutic goods without unlawfully advertising them, while clarifying the legal exceptions available to broadcasters and publishers. Since consultation, the TGA has strengthened the emphasis on public interest journalism, clarified unlawful advertising risks, refined examples involving sponsored content and prescription medicines, and improved the explanation of the legislative framework.
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Health Canada Expands Monthly Device Performance Reporting – Health Canada’s Medical Devices Directorate has moved to monthly public reporting on key regulatory performance metrics, replacing its former quarterly and annual reports. New monthly data includes Market Authorisation Time broken down by time with Health Canada versus industry, applications received by type, time to first decision, screening performance, application backlogs, and ITA/SAP performance against service standards, all available via GCWiki.
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Updated TGA Guidance on Essential Principles Evidence – The TGA has updated its guidance on demonstrating evidence to comply with Australia’s Essential Principles (11 September 2026), alongside updated Clinical evidence guidelines and Real World Evidence pages. Together they clarify evidence expectations under the Essential Principles and the TGA’s position on using computational modelling and simulation (CM&S) in device evidence packages.
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Personal Importation Scheme – in September 2026 changes to the Personal Importation Scheme (PIS) were implemented (media release at link). The PIS allows consumers to import certain therapeutic goods for their personal use. While the media release refers specifically to medicines, the information provided is also applicable to medical devices. Of particular relevance to medical devices are changes to Schedule 4, Item 1.1:
- updated to incorporate the same definition of immediate family, to:
immediate family of a person means:
(a) a spouse, de facto partner, child, parent, grandparent, grandchild or sibling of the person; or
(b) a child, parent, grandparent, grandchild or sibling of a spouse or de facto partner of the person.
- an addition for consistency to ensure goods are clearly identifiable:
(e) in all cases—the device is in packaging that enables the device to be accurately identified.
Should you require additional information, please contact the Medical Devices Information Unit at: devices@tga.gov.au.
Action Items
- TGA Information Sharing Consultation – The TGA is consulting on proposed changes to how it shares information on the safety, quality and performance of medical devices, aligning with the Action Plan for Medical Devices and the requirements set out in WHO’s Global Benchmarking Framework. Proposed changes would give the public more information after post-market reviews or investigations, particularly on safety, quality, performance or use findings. Feedback is sought on whether and what type of information the TGA should share during such reviews. Open for MTAA member input on RegConnect till 25 September 2026.
