THE Therapeutic Goods Administration (TGA) is opening a consultation process seeking input from stakeholders on the regulation of software, including Software as a Medical Device (SaMD).
While software is currently regulated by the TGA under the existing medical device framework, it is not thought to adequately manage the emergence of apps.
The TGA said the new regulations will, where possible, harmonise with international practices.
Visit tga.gov.au for details.
MEANWHILE the TGA is also conducting a webinar on the current regulations around SaMD, on Thu 07 Mar 12.30-13.30.
CLICK HERE for more information and to register.
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