TGA Guidance on Excluded Software: Middleware
The new article describes in detail the regulatory approach to be applied with respect to middleware used for healthcare purposes.
The new article describes in detail the regulatory approach to be applied with respect to middleware used for healthcare purposes.
The new article provides additional clarifications regarding the regulatory approach to be followed with respect to the tools intended to be used for the digitalization of paper-based records used in the healthcare sphere.
The new article describes additional aspects related to the regulatory status of the products for electronic healthcare records.
The new article addresses the regulatory matters related to digital mental health tools, explaining the requirements such products are subject to in accordance with the existing legal framework.
The new article clarifies the exclusion requirements for the software products intended to be used for communication purposes, as well as for administration of healthcare facilities.
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