Australia Medical Device Regulations

All documents listed below are available from the Australian Therapeutic Goods Administration (TGA) website. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in Australia, you may be interested in our custom regulatory strategy reports for Australia.

Please note that this information is copyrighted by the TGA. You may download, store in cache, display, print and copy a single copy or part of a single copy of information or material from this site only for your personal, non-commercial use and only in an unaltered form.

Major Regulations

• Summary of Therapeutic Goods Act 1989
  • Therapeutic Goods Amendment Regulations 2010*
  • Therapeutic Goods (Medical Devices) Amendment Regulations 2010*

*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)
  • Complete ARGMD document
• Summary of Device-medicine boundary products
  • Australian medical devices guidelines: 35. Device-medicine boundary products

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 (pdf,60kb)
  • Request to transfer sponsorship of ARTG Inclusions for medical devices - accepting company

Additional Information

• Summary of TGA fees and charges
  • TGA fees: IVD Pricing Schedule