TGA


The Next Phase of the Global Harmonisation Task Force (GHTF) Evolution...

Recently there has been significant discussion on the future direction of the GHTF. In a statement released on March 28 2011, Larry Kelly, the chair of the GHTF,  confirmed that the current GHTF structure will morph into a Regulator’s Group. This was considered the best way to continue to work towards the objective of harmonised regulatory requirements by GHTF senior officials....

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TGA Release Additional IVD Guidance

New IVD requirements (Regulations implemented on July 1, 2010) have brought a number of challenges for IVD manufacturers and sponsors in Australia. To assist, the TGA have released a number of guidance documents, the most recent being ‘What a sponsor needs to know about conformity assessment and manufacturer’s evidence’. The guidance document is intended to describe the conformity assessment process in detail, along with providing specific instructions relating to manufacturer’s evidence. Despite the release of guidance documents, IVD manufacturer and sponsors still have their work cut out to ramp up regulatory actions......

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Greater scrutiny for in-vitro diagnostic (IVD) devices In-vitro diagnostic (IVD) device companies will soon be subjected to greater scrutiny by Australian regulator, the Therapeutic Goods Administration (TGA). The new rules bring IVDs into line with medical devices by requiring standard technical documentation (STED) and in some cases, a full quality system....

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