Australia: TGA Updates Application Audit Selection Criteria with a Focus on Gynaecological Curettes – August/September 2026

• 2026-09-21 02:28:25

Australia's Therapeutic Goods Administration (TGA) updated its application audit selection criteria guidance, placing heightened pre-market focus on gynaecological curettes under Criterion 3 (Post-market signals). This article outlines how active post-market signals directly trigger non-mandatory application audits for medical devices, details the mandatory audit conditions under Regulation 5.3, and provides practical submission strategies for sponsors seeking Australian Register of Therapeutic Goods (ARTG) inclusion.

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