Medical Device Registration in Australia
Key considerations in navigating the regulatory process to register a medical device in Australia. Registering a medical device in Australia is a complex but crucial process that ensures the safety and performance of devices entering the healthcare market. Navigating the regulatory requirements of the Therapeutic Goods Administration (TGA) can be daunting, particularly for new manufacturers…
How to Register a Medicine in Australia
Six ways to register a medicine in Australia: Understanding the complexities of medicine registration. In the dynamic landscape of pharmaceuticals, securing registration for a new medicine requires a nuanced understanding of regulatory procedures and individual client needs. The process involves meticulous planning and strategic vision to ensure successful registration. However, beyond the intricacies of registration,…
Moderna mRNA COVID-19 Vaccine Approved
09 August, 2021 – Moderna mRNA COVID-19 Vaccine Approved The Therapeutic Goods Administration (TGA) has provisionally approved Moderna’s mRNA vaccine for use in Australia, in record time. Australia’s fourth approved vaccine, one million doses are due to be released in the second half of September, 2021. The Spikevax (elasomeran) vaccine is provisionally approved and included…
Custom-made Medical Devices in Australia: Now it’s Personal(ised)
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 the niche and specialised Custom-made Medical Devices sector. The new guidance reflects amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, meaning that compliance
Is Artificial Intelligence Becoming Too Smart for Regulators?
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 idea has come a long way from concept to reality. From enhancing photos for your social media page to detecting diseases from medical images
Australian Government Cash Splash on High Tech Recovery
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 saw the first Australian federal budget delivered in a recession in 30 years. The Treasurer said personal income tax cuts, infrastructure spending, and business
The Pointy End of the TGA (PI) Reformatting Transition Period
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 or otherwise, you’re required to provide the updated PI to TGA in the new format. The looming deadline for marketed product PIs to be
Therapeutic Product Commercialization Strategy
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 clear regulatory requirements, so they are often first targets for therapeutic product commercialization, either for medicines or medical devices. A New Perspective But what
