PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: USPTO finalizes SAS rule, U.S. senators press case for permanent telehealth, CMS no fan of national coverage policy for Allomap, TGA posts guidance for class I tests, Marburg MCMs protected under PREP.
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices, beginning Dec. 1. New implantable devices will need to comply by Dec. 1, 2020, and existing implantable devices will have until Dec. 1, 2021, to comply.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG).
PERTH, Australia – It was already going to be a busy year for Australia’s Therapeutic Goods Administration (TGA) as it planned to implement the final wave of device reforms in 2020 before the COVID-19 pandemic hit. The delay to the EU Medical Device Regulation (MDR) as a result of the pandemic will mean that Australia will also push back many of its device reforms for another year, said John Skerritt, the TGA’s deputy secretary of the Health Products Regulation Group.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HQO recommends home UVB therapy; Health Canada announces testing advisory panel.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: NIST ramps up Zero Trust cybersecurity program; TGA sets date for mesh up-classification; IMDRF posts post-market study update; ANVISA updates list of non-regulated devices.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking industry feedback on further strengthening reforms for adverse events and postmarket regulations for medical devices.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) said industry stakeholders supported making in vitro diagnostic (IVD) self-tests available for infectious diseases like influenza but self-tests for cancer and genetic testing for health-related purposes should continue to be prohibited from supply.
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