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For a software-as-a-medical-device (SaMD) product with annual software updates, determining what constitutes a significant change requiring new PMCF evaluation adds regulatory complexity to the product development cycle

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Products are not therapeutic goods, are not TGA-approved, and are not for human or animal consumption

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Unlike traditional exfoliating body products that only remove surface buildup, this professional-strength formula combines clinical resurfacing acids with bioactive copper peptide technology to deliver both immediate skin refinement and long-term structural repair