Your leading voice in digital health news
Twitter X Logo

Home
/
News
/
SaMD

SaMD

6 August 2026

ANDHealth expands partnership with TGA

ANDHealth has today announced the renewal and expansion of its partnership with the Therapeutic Goods Administration (TGA) as its core…
Continue Reading
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The Therapeutic Goods Administration (TGA) has opened consultation on a draft guidance document outlining how predetermined change control plans, or…
Continue Reading
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…
Continue Reading
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…
Continue Reading
Load More

Your leading voice in digital health news

Twitter X

Your leading voice in digital health news 

Keep your finger on the pulse with full access to all articles published on 
pulseit.news
Subscribe from only $39
magnifiercrossmenuchevron-downarrow-right