TGA: Australian Regulatory Guidelines for Medical Devices (ARGMD)
Australia's TGA: Listed Medicines Evidence Guidelines
Australia TGA MD Guidance: Essential Principle 13B & Regulation of Software based Medical Devices
TGA Guidance: Insights into Authorized Prescribers, Ventilator Exports, and Excluded Software
TGA Guidance: Regulatory Changes for Software-Based Medical Devices
TGA Guidance: Regulatory Obligations for Exempt Medical Devices
Australia TGA: Regulation of Software based Medical Devices
Australia TGA: Regulatory requirements for in-house IVDs
Australia TGA: Clinical Trial Notification (CTN) Form - User Guide
TGA MD Guidance: Medical Device Labelling Obligations
Australia TGA: eCTD AU module 1 and regional information
Australia TGA: Clinical Evidence Guidelines
TGA Guidance: General Dossier Requirements
TGA Guidance: Submitting data in the eCTD format
Australia's TGA: Reclassification of Medical Devices & Variations to Prescription Medicines
Australia's TGA: Guidance on Regulation of Software based Medical Devices
Australia TGA: FAQ Importing & Supplying Medical Devices
TGA guidance on Testimonials & Endorsements in Advertising
Guidance for Declaration of Conformity - TGA