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BioWorld - Wednesday, December 24, 2025
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Home » TGA launches consultation on mandatory adverse event reporting
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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.
BioWorld MedTech Regulatory Asia-Pacific Australia TGA

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