Australia TGA Medical Device Regulations

All documents listed below are available from the Australian Therapeutic Goods Administration (TGA) website. Please note that this information is copyrighted by the TGA.

Major Regulations

TGA list of all medical device regulations

General Guidance Documents

Australian Regulatory Guidelines for Medical Devices (ARGMD)

IVD Guidance Documents

Summary of 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
- Declaration of Conformity Template For Medical Devices
- Declaration of Conformity Template For IVDs

Additional Information

Schedule of TGA fees and charges

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