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Home » Topics » Regulatory » TGA

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Australia map, flag

Six classes of medical devices reclassified in Australia to align with EU MDR

Nov. 29, 2021
By Tamra Sami
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) 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).
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Flag of Australia, sky background

TGA to refine regulations for devices introduced via body orifices or skin

Nov. 18, 2021
By Tamra Sami
PERTH, Australia – Medical device stakeholders generally opposed the Therapeutic Goods Administration’s (TGA) proposal to refine regulation of devices that consist of substances introduced into the human body via a body orifice or applied to the skin. The agency received 45 comments, 17 of which came from medical device manufacturers or associations representing device manufacturers or sponsors, and most of those comments did not support the proposal to refine the regulations.
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Green approved stamp

TGA greenlights Telix’s PSMA imaging agent Illuccix for prostate cancer

Nov. 5, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Telix Pharmaceuticals Ltd.’s lead prostate cancer imaging agent, Illuccix. Illuccix (TLX591-CDx) is a Gallium-based PSMA imaging agent and cold kit for developing radiopharmaceutical products and diagnostic agents. Telix’s prostate cancer program consists of a companion diagnostic imaging agent (TLX591-CDx) and a therapeutic (TLX-591) to improve the detection and treatment of prostate cancer.
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Australia map, flag

TGA launches consultation on mandatory adverse event reporting

Oct. 29, 2021
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking comments from industry on mandatory reporting of medical device averse events by health care facilities, and the agency also published comments on a consultation on patient information to be provided with devices. As part of the recent overhaul of Australia’s medical device regulations, the TGA released an action plan for medical devices in 2019 that explored whether it should be mandatory for health care facilities to report adverse events and safety problems with devices to the TGA.
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Australian flag marking country on globe

TGA clarifies how active devices, clinical decision software is classified

Oct. 15, 2021
By Tamra Sami
PERTH, Australia – Australia’s TGA issued new guidance to help device manufacturers better understand new classifications for active medical devices, including software-based medical devices, and clinical decision support software.
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Syringe with Johnson & Johnson logo

FDA briefing docs build stronger case for 2nd J&J vaccine dose

Oct. 13, 2021
By Mari Serebrov
Should Johnson & Johnson’s (J&J) COVID-19 vaccine be a two-dose series? While not directly asked, that question almost lurks between the lines of the FDA’s briefing document for the Oct. 15 meeting of its Vaccines and Related Biological Products Advisory Committee. The document referred to J&J’s proposed second dose as a “booster,” but the FDA isn’t asking the committee the questions it posed for the Moderna Inc. and Pfizer Inc.-Biontech SE boosters. Instead, it is inviting VRBPAC to advise on whether the second J&J dose should be administered two months or six months following the first shot.
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TGA recognizes COVID-19 vaccines for travel purposes

Oct. 5, 2021
In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.”
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TGA recognizes COVID-19 vaccines for travel purposes

Oct. 4, 2021
In addition to the four COVID-19 vaccines it has provisionally approved, Australia’s Therapeutic Goods Administration (TGA) is recommending that two more vaccines – Sinovac Biotech Ltd.’s Coronavac and Astrazeneca plc-Serum Institute of India’s Covishield – be considered “recognized vaccines.”
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Australia map, flag

TGA updates industry on device up-classification requirements

Oct. 1, 2021
By Mark McCarty
Australia’s TGA provided updates regarding up-classification of several device types, including a number of spinal implants, which will henceforth be regulated as high-risk, class III devices, rather than medium-to-high risk devices (class IIb).
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Australia and coronavirus

Australia to allow COVID-19 rapid antigen self-tests to be sold to consumers

Sep. 28, 2021
By Tamra Sami
PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.
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