TGA structure. The TGA is part of the Health Products Regulation Group (HPRG) in the Australian Government Department of Health, Disability and Ageing. This pagesummarises the structure of the TGA and the heads of the various divisions.

Listed medicines – compliance and education. TGA priorities are stability and efficacy. This information page is important for all sponsors of listed complementary medicines! Read it here.

Listed medicines that include indications related to diarrhoea and are subject to specific warning statements. The TGA  conducted compliance revies and found that the sponsors of all 15 medicines (100%) responded to the TGA’s request for information, of which 14 medicines (93%) were found to comply with the required warning statement. Full report is on TGA website here.

Exporting medicines from Australia? Including prescription, over-the-counter (OTC) and complementary medicines, either for commercial supply, or for non-commercial purposes (for example, for a family member or friend). Updated guidelines here.

Personal import scheme – revised guidelines. Individuals can legally import most (but not all) therapeutic goods for personal use under the Personal Importation Scheme, provided certain conditions are met. Details provided here.

Buying medicines and medical devices online. A useful new guideline – contains a link to a YouTube video and a transcript of the video – Source: TGA

Adverse drug reaction: 6 information pages published here

Vitamin B6 (pyridoxine, pyridoxal or pyridoxamine) – change to regulation from 1st June 2027: 50 mg or less per recommended daily dose available for general retail sale; more than 50 mg but not more than 200 mg per recommended daily dose will be available over the counter with the advice of a pharmacist; more than 200 mg per recommended daily require a prescription. Source: TGA

How can practitioners access unapproved therapeutic goods. Details who can apply (and who can’t apply), what you can access and what to do before you apply. Read more here. This page also contains links specific to medicinal cannabis, MDMA and psilocybine.

Accessing medical cannabis for a patient. there are four ways a practitioner can access unapproved medicinal cannabis. This article also includes notes about patients under 18 years old.

The risks of buying melatonin online – an information sheet for clinicians and pharmacists, is here. Includes dose inconsistencies in imported products – some products contained up to 400% more melatonin than stated, while others contained less than stated or none – and the risk of accidental overdose in children of products presented as gummies or lolly-like formulations due to their appealing appearance and ease of consumption.

The Poisons Standard

* This appears to be an updated guideline, but it does include scheduling decisions to be implemented in future Poisons Standards, including glyoxylic acid, Camellia sinensisextract (green tea), intravenous potassium salts, and vitamin B6 (see story above). Source: TGA

* The latest version of the poisons standard is February 2026, this can be viewed here.

* This explanatory statement summarises the changes that have been made, including new entries.

* Final decision to amend (or not amend) the current Poisons Standard in relation to adrenaline: links to MS Word and PDF versions of the notice are on this webpage.

International guidelines that have been adopted:

* Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents .. read more here.

* Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract – read more here.

Permission to use a restricted representation about diabetes in advertising has been granted for certain devices. To see which types of devices, what representations have been allowed and what the conditions are, go here.

Acceptable intake for nitrosamines in medicines – updated list of limits is here.

Advisory Committee on Complementary Medicines – statement for meeting in November 2025. Includes classification of menaquinone-7, and safety review of Myristica fragrans (nutmeg/mace). Read more here.

Public and stakeholder consultations:

* Proposed changes to labelling of medicines supplied in Australia – consultation remains open to 10th March 2026. To access the overview, read the consultation and provide your feedback, go here.

* Conformity Assessment Procedures for Medical Devices – Proposed Amendments. Information and link to online survey here.

* Nutrient reference values – the NHMRC is inviting comment on changes to the Nutrient Reference Values for selenium. Consultation closes 18th March. Read more and share your views on NHMRC website here.

Unique Device Identification (UDI) – the TGA has posted 12 different information pages on this topic since our last newsletter was published. To access these, type UDI into the TGA search box and you should arrive at this list.

Digital mental health tools are regulated as medical devices. This page details how they are regulated, when they are not regulated, and some examples.

Software based medical devices must comply with international standards particularly for cyber-security. A list of international standards is available here.

Software-based medical devices information for consumers here and information for health professionals here.

How the TGA regulates software-based medical devices – summary published here.

Understanding digital therapeutics and how the TGA regulates them. Digital therapeutics are not wellness apps. This page contains a helpful summary of the key differences between digital therapeutics and wellness apps.

Wearable medical devices – are products worn on the body that collect health-related data or deliver therapeutic functions. These may include smartwatches, fitness trackers, biosensors, or patches that monitor vital signs or deliver medication. Which ones one are considered to be medical devices? More on TGA website here.

Summary of the TGA’ post market review of ventilator, continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) devices is here.

Consent to supply for medical devices that do not meet the Essential Principles: responsibilities after consent is granted – more here. and this page gives more details on how to apply.

Digital scribes – when are they regulated as medical devices? Digital scribes (also referred to as artificial intelligence (AI) scribes or ambient scribes) are increasingly used in clinical settings to capture conversations between patients and healthcare practitioners. These tools generate clinical notes, summaries or letters which may be added to patient records. And when are they not medical devices. Read more here.

Clinical decision support system software – how is it regulated? An update is here.

Additional medical device news can be viewed on the February 2026 edition of TGA Medical Device Resources published on LinkedIn by Gary Burgess, Hill Valley Regulatory Consulting. 

Advisory committee on medical devices: members announced, details here

Advisory Committee on Vaccines: members announced here.

Advisory Committee on Biologicals: members announced here

TGA’s freedom of disclosure (FOI) log – last updated 19th January 2026, is here.

Medicines and medical devices that have been cancelled or suspended by the sponsor  – no updates since last newsletter

Listed medicine compliance reports. Not updated since last newsletter.

Compliance activity

* TGA has issued infringement notices to Prime Medic Group and an individual for the alleged unlawful advertising of weight loss medicines. One infringement notice for $19,800 was issued to Prime Medic, and one for $3,960 was issued to the individual. Prime Medic operates an online telehealth platform offering consultations with doctors. It is alleged that Prime Medic advertised prescription-only weight loss medicines, Ozempic and Mounjaro, directly to consumers between at least January and July 2025. More information here.

* 11 infringement notices totalling $43,560, have been issued to 6 individuals, including 3 Australian Health Practitioner Regulation Agency (Ahpra) registered health practitioners, for the alleged unlawful importation of unapproved therapeutic goods and the alleged unlawful advertising of therapeutic goods. Products included counterfeit cosmetic injectables, and botulinum toxin type A – a prescription-only medicine. Read more here.

Compliance enforcement

* How the TGA monitors and enforces compliance, published here.

* Compliance management published here.

* Compliance Principles 2026 and 2027. New compliance principles and priority focus areas for 2026 and 2027 relating to the import, export, manufacture, supply and advertising requirements. Read it here. Focus areas up to 31st March 2026:

Direct to consumer in vitro diagnostic (IVD) kits; Erectile dysfunction medications; Foetal dopplers; Listed medicine advertising; Medicinal cannabis; Melatonin; Software as a medical device; Substandard and falsified therapeutic goods; Sunscreen; Weight loss medications; Therapeutic goods used in cosmetic procedures; Vaping goods.

* Infringement notices: search for infringements notices issued by TGA here.

Safety advisories

* Natures Valley Collagen Builder tablets has been tested and found to contain 199.3 milligrams per tablet of undeclared sildenafil which can cause serious side effects. Source: TGA

* H3 Hintermann Ankle Replacement System – all units are being quarantined and  patients, caregivers, and health care providers are being alerted about an increased risk of revision. Source: TGA

* Six imported melatonin products contained significantly more than the labelled amount, and four contained significantly less than the labelled amount. The brands are listed here.

Product correction

* Mindray Medical Australia is conducting a product correction for the BeneHeart C Series Automated External Defibrillator – the operator’s manual is being updated to help users better understand the impact of the Wi-Fi settings on battery life, and information on the electrode pads detection function. More information here.

Recalls

* Comvita MediHoney Antibacterial Wound Gel due to problems with the packaging which may not be sealed properly, which can make the product non‑sterile or cause it to leak –  there may be a risk of product contamination and subsequent infection if the product is used on an open wound Source: TGA

* The Procedure for Recalls, Product Alerts and Product Corrections (PRAC), has officially replacing the Uniform Recall Procedure for Therapeutic Goods (URPTG). Read more here. and Questions and Answers on this topic are here.

* Legislative powers the TGA can use relating to recalls and other market actions – published here

* Recall coordinators: this page lists the contact details for the Australian Government Recall Coordinators. and the State and Territory coordinators for medicines, medial devices and blood and tissues.

Vaping

* 57,000 illegal vaping goods were seized in Burwood (a suburb of Sydney) in an operation involving the TGA, the NSW Police Force and the Australian Federal Police . Source: TGA

* After a search warrant was issued for a pop‑up retail store in Inverloch, Victoria, TGA officers seized a range of unlawful vaping products. The premises was selling illicit vapes to minors and supplying illicit tobacco products. Source: TGA

* Notified vape list: goods for smoking cessation or nicotine dependence. This is a list of products that can be legally supplied in Australia. Healthcare practitioners can use this list when prescribing and supplying unapproved therapeutic vaping goods as they have been notified as complying with applicable standards. Read more and see the list of products here.

USA news contributed by Neil O’Flaherty, from Amin Wasserman Gurnani, LLP

There have been a few U.S. FDA developments that increase the number of wearable and/or digital health products that can be brought to market in the U.S. without active regulation by FDA.

1. Expansion of the scope of “general wellness” products.

By policy, FDA does not subject “general wellness” of products to the Agency’s medical device requirements. FDA has now expanded the scope of “general wellness” products to include non-invasive physiological sensing technologies and related software which meet certain criteria. Included is a link to a copy of FDA’s updated policy. The key new discussion on physiological non-invasive technologies is found towards the end of Section III of the policy.

General Wellness: Policy for Low Risk Devices – Guidance for Industry and Food and Drug Administration Staff

2. Expansion of the scope of “clinical decision support” software which is considered a non-device.

Under the Federal Food, Drug, and Cosmetic Act, “clinical decision support” (CDS) software is not a device if it meets certain criteria. In some respects, FDA has liberalized its views on when the criteria for non-device status are met. Included is a link to a copy of FDA’s updated CDS software guidance document for more details.

Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff

Botanical Adulterants Prevention Programme (BAPP) and similar articles

Compendial Perspectives on Botanical Identity Testing. Published by American Chemical Society and American Society of Pharmacognosy, read it here.

For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.

IN THE PRESS

* Woman hospitalised after Juniper prescribes weight-loss drugs her GP refused. Juniper is a medical telehealth provider. Published in ABC news,

Foods