What the TGA Accepts (and What It Doesn’t) Global medical device manufacturers increasingly approach Australia with confidence. Many arrive with European CE marking or United States Food and Drug Administration (FDA) clearance already secured. On the surface, this creates a perception that entry to the Australian market should be straightforward. In practice, however, the Therapeutic…
Lessons from the March 2026 TRUE METRIX device correction In March 2026, the Therapeutic Goods Administration (TGA) published a market action for the TRUE METRIX® Blood Glucose Monitoring Systems, describing a product correction prompted by gaps in the clarity of the Instructions for Use (IFU). On the surface, the issue related to a single device…
A practical EUDAMED data readiness playbook for manufacturers For many medical device and in vitro diagnostic (IVD) manufacturers, European Database on Medical Devices (EUDAMED) has sat in the background for years, technically available, often partially used, and sometimes deferred in favour of national systems. That period is coming to an end. From 28 May 2026,…
Navigating the 2024 UK Post-Market Surveillance Amendments for Medical Devices In a significant step toward strengthening patient safety and aligning with global best practices, the UK government introduced the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368). These regulations, which amend the UK Medical Devices Regulations ,2002, came into force on…
The future of pharma & medical device manufacturing is already here, and what’s not here yet is rapidly unfolding. There’s a lot to take in this year in terms of industry trends, new technologies, and GxP & GMP compliance guidelines for pharmaceutical and medical device organisations! It would be nice if the latest AI technologies…
Keeping an eye on medical devices isn’t just a regulatory checkbox—it’s a commitment to patient safety and trust in Australia’s healthcare system. This discussion takes you through the critical aspects of medical device vigilance, shedding light on the essential regulations and offering practical tips for manufacturers, sponsors and healthcare providers. The Pulse of Vigilance: Why…
In a world where technology is advancing at an unprecedented pace, the integration of digital health technologies into the healthcare landscape has become increasingly vital. Recognizing the significance of this convergence, the U.S. Food and Drug Administration (FDA) has taken a significant step forward this month (October 2023) by establishing a new Advisory Committee on…
Navigating the Latest TGA Amendments: Essential Information for Class IIa & Class IIb Medical Device Listings Ever since the shakeup of the European Union (EU) Medical Device Regulations (MDR) in 2017, the Therapeutic Goods Administration (TGA) have adjusted their dependence on utilising the EU as their basis for listing on the Australian Register of Therapeutic…
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