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Nov 26, 20232 min read

Australia TGA: Clinical Evidence Guidelines

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance "Clinical Evidence" on 23 November 2023,...

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Oct 31, 20231 min read

TGA Guidance: General Dossier Requirements

Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier...

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Sep 11, 20231 min read

TGA Guidance: Submitting data in the eCTD format

Recently (7th Spetember, 2023) Australia's Therapeutic Goods Administration (TGA) released revised and updated guidance "Submitting data...

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Aug 22, 20232 min read

Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines

Yesterday (21-August-2023) Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...

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Jul 2, 20232 min read

Australia's TGA: Reclassification of Surgical Mesh, Spinal Implants & Completing a Notification Form

Recently on 27th June, 2023 Australia's Therapeutic Goods Administration (TGA) released multiple guidances on the "Reclassification of...

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Jun 4, 20231 min read

Australia's TGA: Guidance on Regulation of Software based Medical Devices

Recently on 2nd June, 2023 Australia's Therapeutic Goods Administration (TGA) released guidance on the "Regulation of Software based...

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Jan 8, 20231 min read

Australia TGA: FAQ Importing & Supplying Medical Devices

Recently on 3rd January, 2023 Australia's Therapeutic Goods Administration (TGA) released a guidance on frequently asked questions...

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