All documents listed below are available from the Australian Therapeutic Goods Administration (TGA) website. Please note that this information is copyrighted by the TGA.
- Summary of Therapeutic Goods Act 1989
*The Major Regulations affecting medical devices and IVDs are available from the Australian Government Attorney General's office.
General Guidance Documents
- Summary of Australian Regulatory Guidelines for Medical Devices (ARGMD)
- Summary of Device-medicine boundary products
Specific Guidance Documents
Forms and Applications
- Essential Principles Checklist (medical devices)
- Forms to Request to Transfer the Sponsorship of an ARTG Entry
- Templates for Declaration of Conformity