Update on TGA Essential Principles Checklist

The Therapeutic Goods Administration (TGA) Essential Principles Checklist V1.2 was recently updated in addition to the previous updates in May 2024.

The Essential Principles Checklist from the TGA is a valuable tool for applying for an Australian Conformity Assessment Certificate. It helps ensure that you have addressed all the TGA requirements for medical device approval in Australia. We highly recommend using the checklist for each new medical device conformity assessment in the country.

In this update:

• • A ‘Products’ line has been added to the first page to more clearly identify the device the checklist applies to, which is particularly useful for users managing multiple checklists.
  • Formatting issues have been resolved, including the removal of unnecessary restrictions and security limitations that previously hindered data entry into the checklist tables.
  • URL links have been attached to each main principle, allowing users to navigate directly to the associated TGA webpage

You can read the full document here.

_____________________________________________

If you have any questions about the TGA’s Essential Principles Checklist or need regulatory help in bringing your medical device to the Australian market, contact us so we can help you.

Learn how MedEnvoy can assist you:

• • TGA Sponsor
  • Swiss Regulatory Importer
  • CE Marking Compliance Consulting
  • EUDAMED Registration