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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
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
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
Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...
Sharan Murugan
Aug 21, 20221 min read
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
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
Updated Prescription Medicines Registration Process – TGA Australia
Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical...
Sharan Murugan
Aug 19, 20212 min read
Regulation & Re-classification of Software based Medical Devices - TGA Australia
Software-based Medical Devices are medical devices that incorporate or are software, including software as a medical device, or software...
Sharan Murugan
Aug 19, 20211 min read
Latest reforms to Post-Market Monitoring of Medical Devices- Australia’s TGA
A recent notice was published by Australia’s TGA details on the latest reforms to post-market monitoring of medical devices. The TGA...
Sharan Murugan
Jul 7, 20211 min read
Australian electronic Submission Basics Guide- Australia (TGA)
eCTD and NeeS are the standard electronic submission formats and allow the Common Technical Document (CTD) structure to be provided in an...
Sharan Murugan
Jun 27, 20211 min read
Reclassification of certain medical devices -Australia-TGA
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019(link is external) were made on 12 December 2019, which...
Sharan Murugan
May 28, 20212 min read
Submitting data in the eCTD format - Therapeutic Goods Administration - Australia
This information is for sponsors and manufacturers wanting to submit data in the electronic Common Technical Document (eCTD) format for...
Sharan Murugan
Apr 10, 20211 min read
Submitting data in the NeeS format - Therapeutic Goods Administration -Australia
This information is for sponsors and manufacturers wanting to submit data in the NeeS format for a: prescription medicine biological...
Sharan Murugan
Apr 10, 20211 min read