UDI and TGA processes

The introduction of Unique Device Identification (UDI) system in Australia impacts some existing processes and requirements.

This includes:

• Patient Implant Cards requirements
• Market action requirements
• Record keeping requirements.

Market actions including recalls, alerts and corrections

Where a UDI is available, you must include it in any:

• recalls
• market action customer letters.

When submitting a new market action notification through the TBS portal, you should enter UDIs in the applicable field on the ‘Product Report’ tab. 

Where a UDI is not available, reports continue as per existing requirements and should include any applicable information. 

Adverse events

Where a UDI is available, you must include it in adverse event reports. 

UDIs on Patient Implant Cards (PICs)

Manufacturers must provide Patient Implant Cards (PICs) and Patient Information Leaflets (PILs) for their implantable medical devices.

You are required to include the following information on a PIC:

• name of the device
• model of the device
• batch code, lot number or serial number of the device
• manufacturer’s name, address, and website.

If available, you must also supply the UDI on the PIC for all implantable devices, including:

• the full UDI (UDI-DI and UDI-PI) in AIDC form
• the UDI-DI in HRI form.

This UDI information is in addition to the information already supplied on the PIC.

You should display the UDI-PI either as a single field or split into the above data elements, per the current PIC requirements.

An example of a PIC with a UDI:

You do not need to supply the UDI on Instructions for Use (IFU), although some manufacturers may choose to do so.

Patient information leaflets

There are no requirements for you to include UDIs on Patient Information Leaflets (PILs). 

As a sponsor, you can choose to submit PILs to the AusUDID for your devices as a URL or a PDF attachment. 

As a sponsor, you are responsible for ensuring the PIL is up to date if submitted to AusUDID. 

Instructions for use

You do not need to supply the UDI on Instructions for Use (IFU) or electronic Instructions for use (eIFU), although as a manufacturer, you may choose to do so.

Certification and audits

You do not need to re-register or re-certify your medical devices when you amend your medical device labelling to meet the UDI requirements. This includes amending other supporting documents.

Record keeping requirements

As a sponsor, one of your existing ongoing responsibilities is to maintain distribution records for medical devices supplied in or exported from Australia, including:

• dates
• batch/lot numbers
• product expiry dates
• volume information such as:
  • records of receipt and shipment from manufacturing sites, including records of shipping and storage conditions where required
  • records of storage and warehousing conditions where required
  • records of distribution to customers, retail outlets, hospitals, suppliers and distributors (including export countries).

We expect you to keep records for 10 years for:

• Class 4 IVDs
• Class III medical devices
• Class IIb implantable medical devices.

For all other classifications, we expect you to keep records for 5 years after you distribute the last product. 

We expect that you include the UDI in your records and keep your records for the applicable time frame based on the device’s classification. 

UDI specific record keeping requirements

As a sponsor, you are responsible for maintaining records showing all UDIs used to identify devices that must bear a UDI on their label. 

Your records should indicate whether a device was directly marked, and whether the Direct Mark DI is the same or different to the Primary DI. You should update your records when you make changes to the Production Identifiers (PIs), to reflect all PIs currently associated with each DI.

Your records should also refer to:

• the location of the DI for the model of device*
• the associated types of PIs in the UDIs for that model of the device such as lot number, batch number, manufacturing date.

*This is part of what you should agree with your chosen Issuing Agency. 

Fees and charges

No fees are applicable for submitting or updating your UDI records in the AusUDID. We have included ongoing management and maintenance of the AusUDID in annual charges.

More information

Patient implant cards and information leaflets