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Australia (TGA) Med Dev User Guide: Completing an Application for Consent to Import, Supply, or Export a Medical Device That Does Not Meet the Essential Principles
The Therapeutic Goods Administration (TGA)Â has released Version 3.0Â of its user guide, effective from March 2025, " Completing an...
Sharan Murugan
4 days ago2 min read
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TGA Guidance: Consent for Non-Compliant Medical Devices that do not meet the Essential Principles
The Therapeutic Goods Administration (TGA)Â has released updated guidance in "Completing an application for consent to import, supply, or...
Sharan Murugan
Mar 112 min read
29 views
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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...
Sharan Murugan
Dec 15, 20242 min read
72 views
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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...
Sharan Murugan
Nov 20, 20242 min read
46 views
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Australia's TGA Good Clinical Practice (GCP) Inspection Program
Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...
Sharan Murugan
Nov 3, 20242 min read
51 views
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Australia TGA: eCTD AU Module 1 and Regional Information v3.2
The Therapeutic Goods Administration (TGA)Â of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...
Sharan Murugan
Oct 2, 20242 min read
58 views
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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...
Sharan Murugan
Jul 29, 20242 min read
31 views
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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...
Sharan Murugan
Jul 13, 20242 min read
18 views
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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...
Sharan Murugan
Jul 6, 20242 min read
26 views
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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...
Sharan Murugan
Jun 23, 20242 min read
33 views
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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"...
Sharan Murugan
May 14, 20242 min read
38 views
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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...
Sharan Murugan
May 1, 20242 min read
20 views
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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...
Sharan Murugan
Mar 31, 20241 min read
116 views
0 comments
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...
Sharan Murugan
Feb 22, 20241 min read
108 views
0 comments
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...
Sharan Murugan
Jan 31, 20241 min read
101 views
0 comments
Australia TGA: Clinical Evidence Guidelines
The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance "Clinical Evidence" on 23 November 2023,...
Sharan Murugan
Nov 26, 20232 min read
32 views
0 comments
TGA Guidance: General Dossier Requirements
Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier...
Sharan Murugan
Oct 31, 20231 min read
217 views
0 comments
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
124 views
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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
39 views
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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
34 views
0 comments