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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...

Sharan Murugan
Sep 11, 20231 min read
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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...

Sharan Murugan
Aug 22, 20232 min read
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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...

Sharan Murugan
Jun 4, 20231 min read
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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...

Sharan Murugan
Jan 8, 20231 min read
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TGA guidance on Testimonials & Endorsements in Advertising
As part of its updated guidelines on testimonials and endorsements in advertising, the Therapeutic Goods Administration (TGA) updated its...

Sharan Murugan
Jun 3, 20221 min read
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Guidance for Declaration of Conformity - TGA
When applying for inclusion in the Australian Register of Therapeutic Goods (ARTG), different classes of medical device require different...

Sharan Murugan
Nov 28, 20212 min read
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