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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,...

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...

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...

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...

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...

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...

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...