We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
HL7 SPL overview
The Health Level 7 (HL7) Structured Product Labelling (SPL) is a document markup standard governed by HL7 International (www.hl7.org) for the transfer of health related data. HL7 SPL is based on extensible markup language (XML).
Medical device manufacturers and sponsors can use the HL7 SPL standard as one of the methods for submitting data to the TGA’s Australian Unique Device Identification Database (AusUDID). This approach is consistent with the method used by the US Food and Drug Administration (USFDA) for electronically submitting data to their UDI database.
We recommend this submission method for users with a high number of UDI records and are familiar with HL7 SPL.
For help or more information, contact the UDI Support Team at UDI@health.gov.au.
HL7 SPL document suite
Please refer to the HL7 published specifications for general details on how to create content of labelling files for HL7 SPL data submission. The SPL specifications can be obtained from HL7 (www.hl7.org).
The TGA’s HL7 SPL document suite provides specific information to support the understanding and use of HL7 SPL for submitting data to the AusUDID. This document suite includes resources such as:
- User guide
- Implementation specification
- SPL code list
- Australian UDI Data Dictionary
- Sample HL7 XML messages.
The table below details each document in the HL7 SPL document suite, including purpose, audience and assumed knowledge.
| Document | Australian UDI Data Dictionary | User Guide | Implementation Specification | Code List | Sample HL7 XML Message |
|---|---|---|---|---|---|
| Purpose | Reference listing of all Australian UDI data elements including:
| Overview of:
| Detailed instructions of:
| Reference listing of codes and elements. | Series of sample HL7 XML messages for data submission and notifications (success and failure), including message annotations explaining the data attributes and intended purpose. |
| Audience |
|
|
|
|
|
| Assumed Knowledge |
| TBS Portal including access provisioning and/or understanding of Oauth 2.0 authentication framework. | HL7 SPL messaging protocols and system integration architecture patterns using XML schemas. | HL7 SPL messaging protocols and system integration architecture patterns using XML schemas. | HL7 SPL messaging protocols and system integration architecture patterns using XML schemas. |
It is important that you review these documents as they contain important information and rules for using the HL7 SPL submission method.
HL7 SPL user types
The HL7 SPL submission method can be used by:
- Manufacturers
- Sponsors
- Third party data providers
- Agents.
Some actions can only be completed by sponsors and manufacturers, such as generating Subscription Keys.
You may choose to use a third party data provider or manufacturer to submit UDI records on your behalf using HL7 SPL.
You do not need to have a TGA Business Services (TBS) account to submit UDI records using HL7 SPL however the transaction must contain the credentials for a valid TBS user. This user must be allocated a Submitter role in TBS, and they must generate the necessary credentials used in the HL7 SPL message.
Getting started
To use the HL7 SPL submission method in the AusUDID, you must:
- Review the HL7 SPL document suite including the User Guide and Implementation Specification
- Contact the UDI Support Team to get your Client ID and Secret
- Acknowledge the AusUDID M2M HL7 SPL Terms and Conditions
- If you are a sponsor or manufacturer, generate your Subscription Key
- If you are a third party data provider, get the Subscription Key from the organisation you are submitting UDI records on behalf of
- Get an Access Token.
Once you are familiar with the AusUDID HL7 SPL submission method rules and requirements and have obtained the necessary credentials, you can begin testing.
Testing HL7 SPL submissions
All HL7 SPL users must first test submitting UDI records to the AusUDID Pre-Production environment. This is to confirm:
- Correct transmission of the HL7 SPL message
- Compatibility with the AusUDID messaging services and platform
- Integrity of the UDI record(s)
- Acceptable system performance and load management
- Correct detection and management of errors.
Note that you must complete testing and provide evidence of completed testing to the UDI Support Team. Your Client ID and Secret cannot be used in the AusUDID Production environment until your testing has been confirmed.
Third party data providers that submit UDI records on behalf of multiple organisations must complete testing for each organisation in the AusUDID Pre-Production environment. Sponsors and manufacturers should ensure that their third party data provider has completed testing prior to providing the Subscription Key to them for the Production environment.
You can find more information on testing requirements, including testing scenarios in the M2M HL7 SPL User Guide.
Submitting UDI records to AusUDID Production
Once you have completed all necessary testing, you must contact the UDI Support Team who will clear your Client ID and Secret for use in AusUDID Production.
Once your Client ID and Secret are cleared for use, you may begin submitting UDI records to AusUDID Production.