Australia
The article highlights the key points related to the application of certain essential principles intended to ensure the safety and proper performance of healthcare products allowed to be marketed and used in Australia.
Australia
The new article provides further details regarding the particular approach to be followed in order to achieve and maintain compliance with the relevant regulatory requirements.
Australia
The article provides an overview of the regulatory requirements various sterility products are subject to in order to be allowed for marketing and use in Australia.
Australia
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.
Australia
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.
Australia
The new article provides further clarification regarding the regulatory status of the software products intended to be used for patient image transmission, alerts for healthcare professionals, and clinical workflow management.
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