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 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.
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.
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.