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BioWorld - Wednesday, May 13, 2026
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Home » TGA revisits framework for audits for devices entering Australian market
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TGA revisits framework for audits for devices entering Australian market

July 26, 2023
By Mark McCarty
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.
Medical technology Regulatory Medical devices Asia-Pacific Australia TGA

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