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Sharan Murugan
Dec 15, 20242 min read
TGA: Australian Regulatory Guidelines for Medical Devices (ARGMD)
The Australian Regulatory Guidelines for Medical Devices (ARGMD) , issued by the Therapeutic Goods Administration (TGA), provide a...
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Sharan Murugan
Nov 20, 20242 min read
Australia's TGA: Listed Medicines Evidence Guidelines
Earlier today (20 November, 2024) the Therapeutic Goods Administration (TGA)Â released Version 4.0 of its Listed Medicines " Evidence...
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Sharan Murugan
Jul 29, 20242 min read
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
Australia's Therapeutic Goods Administration (TGA) provided comprehensive guidance on "Essential Principle 13B", which pertains to the...
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Sharan Murugan
Jul 13, 20242 min read
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software
Navigating regulatory requirements is crucial for pharmaceutical and medical device companies to ensure compliance and facilitate smooth...
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Sharan Murugan
Jul 6, 20242 min read
TGA Guidance: Regulatory Changes for Software-Based Medical Devices
The Therapeutic Goods Administration (TGA) has released updated guidance (03 July, 2024) "Regulatory Changes for Software-Based Medical...
23 views0 comments
Sharan Murugan
Jun 23, 20242 min read
TGA Guidance: Regulatory Obligations for Exempt Medical Devices
The Therapeutic Goods Administration (TGA) in Australia has issued guidance (21 June, 2024) on the "Regulatory Obligations for Exempt...
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Sharan Murugan
May 14, 20242 min read
Australia TGA: Regulation of Software based Medical Devices
On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices"...
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Sharan Murugan
May 1, 20242 min read
Australia TGA: Regulatory requirements for in-house IVDs
Today (01 May 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance "Regulatory requirements for in-house...
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Sharan Murugan
Mar 30, 20241 min read
Australia TGA: Clinical Trial Notification (CTN) Form - User Guide
On 28th March, 2024 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "Clinical Trial Notification...
104 views0 comments
Sharan Murugan
Feb 22, 20241 min read
TGA MD Guidance: Medical Device Labelling Obligations
On Monday (19 February, 2024) Australia's Therapeutic Goods Administration (TGA) released updated guidance on the "Medical Device...
104 views0 comments
Sharan Murugan
Jan 31, 20241 min read
Australia TGA: eCTD AU module 1 and regional information
Australia's Therapeutic Goods Administration (TGA) released updated guidance "eCTD AU module 1 and regional information" on 30 January...
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Sharan Murugan
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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Sharan Murugan
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...
214 views0 comments
Sharan Murugan
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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Sharan Murugan
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...
38 views0 comments
Sharan Murugan
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...
31 views0 comments
Sharan Murugan
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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Sharan Murugan
Jun 3, 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...
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Sharan Murugan
Nov 28, 20212 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...
140 views0 comments