NOTIFICATION FORM: Clinical decision support software exemption

Overview

This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002.

The exemption applies to medical devices that are clinical decision support software (CDSS) that meet all three of the following criteria:  

1. intended by its manufacturer to be for the sole purpose of providing or supporting a recommendation to a health professional about preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; and
2. not intended by its manufacturer to directly process or analyse a medical image or signal from another medical device; and
3. not intended by its manufacturer to replace the clinical judgement of a health professional in relation to making a clinical diagnosis or decision about the treatment of patients

The sponsor of the device must use this form to notify the TGA of any importation or supply of the exempt CDSS in Australia within 30 days from the date of importation or supply.

For further information about this exemption and clinical decision support software, please refer to the clinical decision support guidance document.