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Enter the Dragon: Navigating Hong Kong’s Medicines Regulatory System in 2024
Enter the Dragon: Navigating Hong Kong’s Medicines Regulatory System in 2024
Blog article08 Feb 2024
The Year of the Dragon stands as a fitting emblem for Hong Kong’s medicines regulatory system, symbolising strength, resilience, and vigilant...
Custom-made Medical Devices in Australia: Now it’s Personal(ised)
Custom-made Medical Devices in Australia: Now it’s Personal(ised)
Blog article05 Mar 2021
Recent changes in TGA Medical Device Regulations In December 2020, TGA released a new Personalised Medical Device Guideline along with a suite of new names and definitions that have shaken up...
Is Artificial Intelligence Becoming Too Smart for Regulators?
Is Artificial Intelligence Becoming Too Smart for Regulators?
Blog article28 Jan 2021
Is Artificial Intelligence Becoming Too Smart for Regulators? AI is Everywhere and it isn’t that New! The term ‘artificial intelligence’ (AI) was first coined in the 1950s. Since then, this disruptive...
EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?
EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?
Blog article26 Nov 2020
The long-awaited transition to the EU Medical Devices Regulation (MDR) is looming. The regulatory realm of medical devices is in a state of flux and poised on the brink of the...
Australian Government Cash Splash on High Tech Recovery
Australian Government Cash Splash on High Tech Recovery
Blog article15 Oct 2020
Australian science and technology sectors are talking about a ‘research revival’ as the Federal Government splashes the cash in the 2020 Budget. 2020 Budget Cash Splash Thanks to COVID-19, early October...
The Pointy End of the PI Reformatting Transition Period
The Pointy End of the PI Reformatting Transition Period
Blog article20 Mar 2020
By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia. Each time you make a change to a PI, be it safety-related...
Therapeutic Product Commercialization
Therapeutic Product Commercialization
Blog article11 Mar 2020
We may have a global market but do we really consider options outside of USA and EU when developing our Therapeutic Product Commercialization strategy? The USA, EU/UK are large markets with...
Australian Employment Regulations
Australian Employment Regulations
Blog article14 May 2019
Today, we are pleased to introduce one of our affiliates and guest blogger, Anna Pannuzzo from WorkPlacePLUS. In this post, Anna discusses some key workplace health, safety and other legal aspects...
Advertizing Therapeutic Goods in Australia
Advertizing Therapeutic Goods in Australia
Blog article18 Jan 2019
If you’re advertizing therapeutic goods in Australia in 2019, there’s new legislation that is critical to your successful campaign/s. We’ve been keeping up to date over the break to ensure we’re ready...

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