Updated TGA Essential Principles Checklist

The Therapeutic Goods Administration (TGA) has released an updated version of the Essential Principles (EP) checklist for medical devices and IVDs. The checklist is a core tool to demonstrate compliance with the Australian Essential Principles for safety and performance. 

To learn more about MedEnvoy’s Australian TGA Sponsor service, click here.

The September 2025 update to the TGA Essential Principles Checklist specifically addresses the requirements of the Unique Device Identification (UDI).  

The Therapeutic Goods Administration (TGA) officially introduced the Unique Device Identification (UDI) regulatory framework on 24 March 2025. The rollout is phased over five years, with high-risk devices required to comply first, followed by medium- and low-risk categories (Complying with the Unique Device Identification timeframes for medical devices | Therapeutic Goods Administration (TGA)).  

What Has Changed? 

The latest update formalizes UDI obligations for manufacturers and sponsors, aligning Australia more closely with international standards like those in the EU and US. The changes to the Essential Principles Checklist are as follows:    

• Addition of EP 13.5: UDI medical devices—UDI device identifier and UDI production identifier.

• Addition of EP 13.6: UDI medical devices—medical device packaging identifier. 

• Revisions to EP 13.A.2: Patient implant cards etc. for implantable devices (specifically 13.A.2(1)).

• Addition of EP13C: Rules for UDI medical devices.

In summary, here is what these additional Essential Principles requirements cover: 

• UDI Assignment Requirements. 

• Manufacturers must assign both a UDI-DI (Device Identifier) and UDI-PI (Production Identifier) to applicable devices. 

• Triggering New UDIs. 

• Changes in sterility, material composition, software version, or packaging may require a new UDI to be issued. 

• Direct Marking for Reusables. 

• Certain reusable devices must now have the UDI directly marked on the device itself—unless it compromises safety or performance. 

• Data Submission to AusUDID. 

• UDI data must be submitted to the Australian UDI Database (AusUDID) within 30 days of supply in Australia. 

• Checklist Integration. 

• The updated checklist now includes a section for EP13C, prompting manufacturers to document how they meet these traceability requirements. 

Why It Matters 

These improvements streamline the compliance process and align with the requirements of the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025.This addition is a major step toward improving post-market surveillance, recall efficiency, and overall device traceability in Australia. 

The updated checklist is available directly on the TGA website and can be found here. 

How MedEnvoy Can Help

MedEnvoy offers expert regulatory support to manufacturers in navigating TGA regulation requirements including understanding the updated TGA Essential Principles checklist. Our expertise ensures that your registration meets the applicable standards, enabling safe ongoing compliance. We encourage you to contact our team for tailored support. With expertise across both traditional devices and digital health solutions, MedEnvoy ensures your products remain compliant and ready for market access in Australia.