PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.
PERTH, Australia – Australia will be phasing out the Astrazeneca COVID-19 vaccine by October and will rely on Pfizer Inc./Biontech SE and Moderna Inc. vaccines to ramp up lagging vaccination rates.
PERTH, Australia – After unveiling its new regulatory framework for custom-made and 3D-printed devices, Australia’s Therapeutic Goods Administration (TGA) is now proposing further refinements due to pushbacks from stakeholder that manufacture custom-made and patient-matched devices.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) will begin accepting applications from domestic companies to become conformity assessment bodies (AU CAB) beginning July 1. The aim is to allow approved Australian corporations to issue conformity assessment certification for medical devices under Australian law to align with the country’s essential principles.
PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference.
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
PERTH, Australia – Australia’s TGA issued final guidance on clinical evidence requirements for medical devices in response to updated regulations that have resulted in changes to evidence requirements. Clinical evidence is required for all medical devices and in vitro diagnostics (IVDs) that are listed on the Australian Register of Therapeutic Goods (ARTG). The clinical evidence requirements apply when a device is first listed as well as over the lifecycle of the device. If safety issues are identified, the TGA may ask manufacturers to update clinical information to more accurately reflect risk.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.
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