Australia’s Therapeutic Goods Administration has made a few adjustments to its advertising guidelines for social media promotions, including the requirement that the manufacturer is responsible for anything posted by influencers who are acting on behalf of the manufacturer.
Australia’s Therapeutic Goods Administration (TGA) made significant changes to some of its regulations, including those for software-based medical devices. The TGA said that entities that are switching their products to a higher risk classification can continue to offer them for six months after Nov. 1, 2024, if they have an application on file with the TGA, but only if the sponsor notified the agency of such intent prior to May 25, 2022.
Mexico’s Federal Commission for Protection Against Sanitary Risk (COFEPRIS) has released a draft proposal that would overhaul the 2008 version of the rule for device labeling, a document that includes several key proposed reforms.
Australia’s Therapeutic Goods Administration (TGA) proposed in July 2023 to develop a framework for audits for premarket device applications, but the Medical Technology Association of Australia (MTAA) registered several concerns about the proposal.
Australia’s Therapeutic Goods Administration (TGA) posted a Sept. 6 hazard alert for the Scandinavian Total Ankle Replacement (STAR) device by DJO Global, a subsidiary of Wilmington, Del.-based Enovis Corp. TGA said the polyethylene insert used to eliminate friction between the device’s moving parts has demonstrated a higher-than-expected fracture rate, and that the device has been delisted from the Australian Register of Therapeutic Goods (ARTg).
Australia’s Therapeutic Goods Administration (TGA) has issued a regulatory proposal regarding the agency’s approach to audits for devices, a proposal that might reduce the number of these audits. TGA said it may limit audits to the highest-risk devices and may eliminate them for devices that have been granted market access in other regulatory jurisdictions.
Australia’s Therapeutic Goods Administration (TGA) has made a range of changes to its medical device regulations in recent years that have largely been driven by the need to keep pace with changing technologies, TGA head John Skerritt said during the Ausmedtech 2022 annual conference in Melbourne, Australia.
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
