Australia TGA Medical Device Regulations
General Guidance Documents
Summary of Australian Regulatory Guidelines for Medical Devices (ARGMD)
Summary of Device-medicine boundary products
Australian medical devices guidelines: 35. Device-medicine boundary products
Major Regulations
Summary of Therapeutic Goods Act 1989
Therapeutic Goods Amendment Regulations 2010
Therapeutic Goods (Medical Devices) Amendment Regulations 2010
Specific Guidance Documents
Summary of Labelling and Packaging
Summary of IVD Guidance Documents
Forms and Applications
Essential Principles Checklist (medical devices)
Forms to Request to Transfer the Sponsorship of an ARTG Entry
Request to transfer the sponsorship of an ARTG entry – relinquishing company
Request to transfer the sponsorship of an ARTG entry – accepting company
Request to transfer sponsorship of ARTG Inclusions for medical devices – accepting company
Templates for Declaration of Conformity
Declaration of Conformity Template For Medical Devices
Declaration of Conformity Template For IVDs
Additional Information
