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Sharan Murugan
1 day ago2 min read
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...
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Sharan Murugan
Mar 112 min read
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...
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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
Aug 21, 20221 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...
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