Australia updates Prescribed List for 1 November
Australia's November Prescribed List update takes effect on 1 November 2026 under newly registered rules replacing the No. 3 rules.
Australia
MedTech Current regulatory intelligence and device recall publications for Australia.
TGA Review Identifies Gaps in Digital Mental Health Exclusion Criteria
The TGA has completed its review of the conditional exclusion for certain digital mental health tools, finding that the criteria may allow higher-risk products to remain outside its oversight. Public consultation on regulatory options is planned for 2026; the update does not establish a final replacement rule or commencement date.
TGA opens consultation on 2027–28 fees and charges
The TGA is seeking feedback on proposed fees and charges for 2027–28 before requesting Government approval. The consultation closes on 16 November 2026.
TGA digital scribe review clarifies medical-device boundaries
The TGA's review identifies potentially regulated functions in eight of 12 digital scribes. Intended purpose, clinical outputs and conditional CDSS exemptions determine the applicable regulatory position.
Australia Adds PFHpS, PFNS and PFDS to IChEMS Schedule 7 From 1 January 2027
Australia’s 2026 IChEMS amendment places PFHpS, PFNS, PFDS and related chemical classes in Schedule 7 from January 1, 2027. The instrument confirms restrictions on industrial-chemical uses, but the available sources do not establish a blanket TGA exemption for all medical devices or components.
Australia TGA Clarifies Scope and Boundaries for CDSS Software Exemption
Australia's TGA announced amendments clarifying the Clinical Decision Support System exemption effective 1 November 2026, defining boundaries between excluded software, exempt CDSS, and regulated SaMD.
Australia TGA Reclassifies Saline Flushing and Patency Devices to Class IIa
Under new Clause 2.2 of Australia's medical device regulations, non-invasive devices containing only saline for flushing or maintaining device patency are reclassified as Class IIa, with a five-year transition for existing products.