Australia TGA Medical Device Regulation

Australia TGA Medical Device Regulations


General Guidance Documents

Summary of Australian Regulatory Guidelines for Medical Devices (ARGMD)

Complete ARGMD document

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

Schedule of TGA fees and charges

TGA fees: including Medical Devices and IVDs

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