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 landscape of the Therapeutic Goods Administration (TGA) can be daunting, particularly for new manufacturers and innovators.

Navigating the complexities of product development, clinical development, regulatory services for product registration/ lifecycle management, quality/QMS, training and commercialisation requires a tailored approach that balances local requirements and global objectives.

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? 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 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

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

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