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Using the AusUDID Pre-Production environment to test UDI record submissions

Understand the AusUDID Pre-Production environment and how you can use it to ensure compliance with the UDI requirements.

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The Australian Unique Device Identification (AusUDID) Pre-Production environment lets you practice using the AusUDID without affecting real UDI records.

You can test data, system features and workflows in a safe setting. This helps you to find and fix errors before you submit data to the AusUDID Production environment. It also builds your understanding to support compliance with UDI requirements.

Before you use the AusUDID Pre-Production or Production environments, you should understand:

AusUDID environments

The AusUDID has 2 environments. Each environment supports different activities.

AusUDID Production

The AusUDID Production environment (referred to as the AusUDID) is the live database. You must publish your UDI records here to meet UDI compliance requirements. The UDI record must also link to the relevant ARTG inclusion(s).

Patients, consumers, clinical quality registries and health professionals can access this medical device information.

AusUDID Pre-Production

The AusUDID Pre-Production environment runs alongside the live database.

You can use it to familiarise yourself with the AusUDID, including testing of:

  • submission methods
  • data elements and requirements
  • database functionality.

Sponsors or manufacturers using the machine to machine methods must complete testing in the AusUDID Pre-Production environment before submitting to AusUDID Production. You are not required to complete testing if you are using the AusUDID portal or Australian UDI Bulk Upload Template to submit UDI records. However, we recommend all users test in the AusUDID Pre-Production environment.

Note:

Data you submit to the AusUDID Pre-Production environment does not transfer to the AusUDID Production environment.

AusUDID Pre-Production data will not be considered compliant with UDI requirements. It is for testing purposes only.

We do not guarantee or warrant the accuracy, reliability, completeness, currency or usefulness of the information published in the Pre-Production environment. Only data from the AusUDID should be used for any purpose outside the context of testing.

Using real data in AusUDID Pre-Production

When testing UDI record submissions in the AusUDID Pre-Production environment, you must provide the following real data:

  • Manufacturer ID
  • ARTG ID.

This data cannot be fabricated, as the AusUDID Pre-Production validates this against real data. You may choose to fabricate other data and test different combinations of data to familiarise yourself with the AusUDID.

However, we encourage you to enter as much real and complete data as possible. Realistic data creates a testing experience that closely reflect the experience you will have in the AusUDID Production environment.

This approach:

  • improves testing quality
  • helps identify issues early
  • shows how UDI records will display in AusUDID Production
  • reduces errors and non-compliance risks.

Types of AusUDID Pre-Production testing

You should complete several testing scenarios before submitting to the AusUDID Production environment.

Creating, editing and submitting data

Test the full submission process. This ensures your data flows correctly and highlights gaps or errors before submission to the live database.

Test different submission methods

You may wish to try different submission methods in the AusUDID. You can try the AusUDID portal, Australian UDI Bulk Upload Template, HL7 SPL or the National Product Catalogue. Trying out different submission methods helps you select the best submission method for your UDI records.

For more information on submission methods, see: AusUDID submission methods.

Editing data inside and outside of the Grace Period

Testing how updates behave during and after the Grace Period. This helps you understand how UDI Trigger rules apply and how they are enforced. Learn about grace period and trigger elements here: UDI record concepts.

Note:

The AusUDID Pre-Production Grace Period is 1 day. This is shorter than the AusUDID Production Grace Period, allowing you to test updates and corrections to UDI records without waiting the full 30 days.

Using the bulk delete functionality

You can delete your test UDI records in bulk in the AusUDID Pre-Production environment. This allows you to remove your test data without impacting live data. You can use this feature to retest data submissions or remove data you do not wish to be retained in the AusUDID Pre-Production environment.

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