Australia TGA Releases Guidance on Exemption for Certain Clinical Decision Support Software

The Therapeutic Goods Administration (TGA) Australia has released the first version of the guidance document on Exempt Clinical Decision Support Software (CDSS) in August 2022. 

CDSS is used during clinical practice and facilitates in a wide range of functions. Some CDSS can be exempted from certain regulations and that includes software involved in electronic medical records (EMRs), electronic health records (EHRs), or clinical information systems (CISs). 

The consideration for exemption will allow sponsors, manufacturers, suppliers, and software developers to have lesser regulatory burden. However, all the exemption criteria listed in the guidance must be fulfilled. 

More details can be found in “Exemption for Certain Clinical Decision Support Software: Guidance on the exemption criteria, Version 1.0, August 2022”:  

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