TGA Essential Principles Checklist: What do you need to know

The Therapeutic Goods Administration (TGA) has introduced a major update to the Essential Principles (EP) checklist for medical devices and in vitro diagnostics (IVDs), effective September 2025.

This update incorporates new requirements related to the Unique Device Identification (UDI) framework—an important step in strengthening device traceability, post-market surveillance and regulatory alignment with international standards such as those in the EU and US.

For medical device manufacturers and sponsors, these changes bring both opportunity and complexity. Compliance with the Essential Principles is not optional, it is a legal requirement for maintaining inclusion on the Australian Register of Therapeutic Goods (ARTG).

With the rollout of UDI obligations underway, companies operating in Australia’s medtech sector must ensure that their documentation, labelling and traceability systems meet the updated regulatory expectations.

At Lodestar Legal, our Med-Tech Regulatory Lawyers understand the challenges this creates. Our firm has extensive experience advising clients in the medical technology and life sciences industries, guiding them through every stage of product development, registration and compliance under the TGA framework.

The revised checklist introduces several new elements, including:

• EP 13.5 and 13.6 – Requiring assignment of a UDI-DI (Device Identifier) and UDI-PI (Production Identifier), and inclusion of UDI information on device packaging.
• EP 13.A.2(1) – Updated obligations for patient implant cards for implantable devices.
• EP 13C – A new section setting out rules for UDI implementation and documentation within the compliance checklist.

Manufacturers must now ensure that:

• UDIs are assigned correctly and updated when material changes occur.
• Reusable devices are directly marked with the UDI where appropriate.
• Data is submitted to the Australian UDI Database (AusUDID) within 30 days of the device being supplied in Australia.

These changes are more than administrative, they are designed to enhance patient safety, improve recall responsiveness and support global market harmonization.