TGA Australia proposes regulations for Software As A Medical Device (“SaMD”)


TGA is proposing to treat software as a medical device in its own right. Presently it’s only regulated as part of another medical device used to treat patients if it could cause harm to patients. The new reforms would treat the software as a medical device directly if it’s used by medical practitioners to diagnose patient conditions (different levels for critical outcomes diagnosis or just screening). The new proposed regulations are based on
International Medical Devices Regulators Forum (IMDRF) guidelines.

See the following Source for further details.

Source: http://www.mondaq.com/article.asp?articleid=791862&email_access=on

Adopting AS/NZS 62368.1 into national comms cable component and wiring standards (Australia)


Communications Alliance has published two draft standards for public comment on their web site, which now incorporate the principles of the new hazards-based standard: AS/NZS 62368.1:2018 (IEC 62368-1 2nd ed [MOD]). There is also an explanatory background paper. Public commenting closes on 24 May 2019. The standards are:

DR AS/CA S008:2019 Requirements for customer cabling products, and
DR AS/CA S009:2019 Installation requirements for customer cabling (Wiring rules)

Background Paper: DR S008 & DR S009 public comment background paper

The drafts are available for download from Communications Alliance at the following web address:

https://www.commsalliance.com.au/Documents/public-comment

Draft: DR S008_2019 (1,025 KB)

Draft: DR S009_2019 (2,442 KB)

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