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23 April 2026

TGA consults on predetermined software changes

The Therapeutic Goods Administration (TGA) has opened consultation on a draft guidance document outlining how predetermined change control plans, or…
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9 May 2025

App or Medical Device? Why you need to know the difference

A medical regulation expert says consumers should be demanding more information from app developers and vendors, to determine whether certain…
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4 April 2019
 | 1 Comment

Blunt tool: MSIA rejects proposed TGA regulations on medical software

The proposed regulation of software as a medical device by Australia's Therapeutic Goods Administration has been rejected outright by the…
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