Form: Confirmation of M2M HL7 SPL testing completion

Overview

This form is for medical device sponsors, manufacturers, or agents.  

It lets you advise the Therapeutic Goods Administration (TGA) that you confirm that your organisation has completed M2M HL7 SPL testing in accordance with the validation procedure in the M2M HL7 SPL – User Guide – AusUDID and is ready to submit UDI records to the AusUDID Production environment, using HL7 SPL.  

In particular, the confirmation is designed to reflect that you have undertaken all necessary testing and are able to confirm that:  

1. You have identified and resolved issues that may affect the accuracy of UDI records. 
2. Your systems and processes can manage data volumes, and handle updates or corrections to data in the AusUDID. 

[Third party data providers are not required to complete this form, as they are not the owners of the data.]

Important information: 

You cannot submit data to the AusUDID Production environment using M2M HL7 SPL until this form is completed.  

For more information on using the M2M HL7 SPL submission method in the AusUDID, see: Submitting UDI records using HL7 SPL | Therapeutic Goods Administration (TGA). 

Representing other organisations: 

In some circumstances, a sponsor, manufacturer or agent may represent multiple organisations. For example, a sponsor may represent multiple manufacturers or subsidiaries. In this scenario, this form allows you to confirm you have completed the mandatory testing for one organisation that may represent multiple organisations.  

Why your views matter

Completing this form helps the TGA confirm that: 

• your organisation meets the requirements to use the M2M HL7 SPL submission method 
• you have identified and resolved issues that may affect the accuracy of UDI records 
• your systems and processes can manage data volumes, and handle updates or corrections to data in the AusUDID.