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Jul 292 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...

Jul 62 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...

May 142 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"...

May 62 min read

UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device

Last Friday (03 May 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Software and...

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...

Mar 22, 20231 min read

UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD

Earlier today (22 March 2023) UK Medicines and Healthcare products Regulatory Agency released updated guidance on "Crafting an intended...