All documents listed below are available from the Australian Therapeutic Goods Administration (TGA) website. Please note that this information is copyrighted by the TGA.
- TGA list of all medical device regulations
General Guidance Documents
IVD Guidance Documents
Forms and Applications
- Essential Principles Checklist (medical devices)
- Notification of a Change (Transfer) in Sponsorship of an ARTG Entry
- Templates for Declaration of Conformity