Clinical Decision Support Software Exemption Notification Form
The TGA has established a notification form for Australian manufacturers or sponsors of clinical decision support software that meet exemption criteria under the Therapeutic Goods (Medical Devices) Regulations 2002. This exemption applies to medical devices classified as clinical decision support software that meet specified regulatory requirements.
Manufacturers and sponsors placing medical devices on the Australia market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗