Medical Devices

  • Medical Device Registration in Australia

    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…

  • Custom-made Medical Devices in Australia: Now it’s Personal(ised)

    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?

    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

  • EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?

    EU MDR: Are ROW Device Sponsors Ready for the Ripple Effect?

    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 most significant change to the landscape in decades. Despite the postponement of the EU Medical Devices Regulation’s implementation to May 2021 appearing to offer

  • Australian Government Cash Splash on High Tech Recovery

    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

  • Therapeutic Product Commercialization Strategy

    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

  • MEDSAFE NZ Moves Ahead in 2020

    MEDSAFE NZ Moves Ahead in 2020

    Since 2015, Medsafe NZ, the New Zealand Medicines and Medical Devices Safety Authority, has been working on a new therapeutic products regulatory regime to replace and modernise the regulatory arrangements for medicines, and provide regulation of all therapeutic products. Whilst we are still waiting for the progression of the Therapeutic Products Bill through parliament, the