Best practice for submitting UDI records to the AusUDID

Ensure your data is accurate

Essential Principle 13C.4 requires all information in the Australian Unique Device Identification Database (AusUDID) to be accurate and up to date. Incomplete or incorrect submissions can cause validation errors, misidentification of devices, and reduced confidence in Unique Device Identification (UDI) data across the healthcare system.

To ensure your data is accurate and up to date:

• Work closely with your manufacturer to confirm device data.
• Use the Australian UDI Data Dictionary to check definitions and permitted values, and understand which data elements are mandatory, optional, or conditionally mandatory.
• Test your data submission as early as possible.
• Submit your first UDI records manually to ensure your data passes validation.
• Review UDI records after submission to confirm accuracy.
• Ensure consistency with device labelling and the relevant Australian Register of Therapeutic Goods (ARTG) inclusion.
• Do not leave relevant fields blank. Missing data reduces the value and usability of your UDI record.
• Check formatting and spelling to avoid errors.

Maintain your data

Your UDI records must stay accurate after submission. Where data changes, you must take action within 30 days of the change:

• When non-UDI Trigger data elements change, you must update the UDI record to reflect this.
• When UDI Trigger data elements change, you must create a new UDI record. You must not correct an existing UDI record. If you identify an error with a UDI Trigger data element, use the corrections functionality to correct the error.
• You can maintain the data through the AusUDID portal or your chosen submission method.

Best practice tips

• Update non-UDI Trigger data elements as soon as possible.
• Create a new UDI record as soon as possible when a UDI Trigger data element changes.
• Review your UDI records regularly to ensure they are accurate and up to date.
• Agree with your manufacturer to notify you of any changes.

Making your UDI record useful for users

User‑friendly UDI records that are clear, consistent, and well-structured help AusUDID users quickly find and understand medical device information.

Free text fields

When entering information into free text fields as part of your UDI record, always provide clear, end user‑relevant information. Avoid internal codes, technical shorthand, or terminology that are not useful to customers or clinicians. Where possible, align wording with IFUs, labels, or other materials to maintain consistency.

The Australian UDI Data Dictionary provides detailed definitions and permitted values for all data fields under UDI records.

Tips for improving your UDI record

Including clear and relevant information significantly improves the clarity, usefulness and discoverability of your UDI record.

This helps healthcare professionals, clinicians, and consumers understand and differentiate your device.

Best practice tips

• Include clear, specific Device Descriptions.
• Align optional data with labelling, Patient Information Leaflets (PILs) or Instructions for Use (IFUs).
• Consider your audience. Include information that helps users understand the device.
• Use optional fields to highlight important distinguishing features.

Brand name

Brand Name refers to the trade name or product line under which the device is marketed to end users. The Brand name must be relevant to the end user and/or represent a proprietary name. It should be recognisable to sponsors and manufacturers, as well as to customers and clinicians, as the product family or brand. Generally, the Brand Name should not be the same as the Model name.

Device Description

The Device Description helps users understand what the device is and how it differs from similar devices. A clear description improves identification and differentiation of devices and UDI records. 

Best practice tips

• Be specific. Avoid vague terms like ‘medical device’. Instead, describe the device’s function, intended use, and key features.
• Use plain language. Write for a broad audience, including clinicians, patients and procurement teams.
• Include distinguishing details. Include size, materials or other attributes that help differentiate your device from similar products.
• Align with existing information. Align with product packaging or information included in the ARTG entry.

Example: Useful Device Description

Sterile, single‑use peripheral IV catheter designed for short‑term vascular access. The device features a flexible polyurethane cannula, an integrated safety shield to reduce needlestick risk, and a 22‑gauge, 25 mm catheter length suitable for adult and pediatric use.

Example: Vague Device Description

This is a medical device used in hospitals. It helps with procedures and is made of metal materials. It comes in different sizes.

Catalogue number

The Catalogue Number is important as it serves as a link between the sponsor and healthcare organisations that use the device. This linkage is critical in transition to use and adoption of UDIs.

It may be present on the label, or it may be used in business and clinical transactions. You should provide the catalogue number that healthcare or procurement teams would be most likely to use when reordering the device, to make it easier to identify.

Best practice tips

• Use the catalogue number from your product labelling. This should match what appears in packaging or ordering systems.
• Avoid internal-only codes. Do not use internal reference numbers that are not visible or relevant to the users.
• Include formatting if relevant. If your catalogue number includes dashes, spaces or prefixes, enter it exactly as it appears on the label.
• Use a relevant replacement where required. If your device does not have a catalogue number, include a reference, reorder or product number most used for business or clinical transactions. Ensure the data is relevant to data users.

Clinical size

The clinical size provides users with the clinically relevant physical dimensions of a device, helping differentiate versions or models based on characteristics such as length, diameter, gauge, or volume.

Clinical size is mandatory where a device is available in more than one size.

Best practice tips

• Use numeric measurements wherever possible. Numerical values (e.g. 5 mm, 2.5 mL, 14G) provide clarity, support structured data analysis, and minimise interpretation errors.
• Use text only when necessary. The ‘Clinical size text’ is appropriate to use only when the required size information is not available in the predefined list of size types. Keep the text clear and concise.
• Align with existing information. Ensure consistency with your product packaging or information included in the ARTG entry.

Storage and handling

The storage and handling conditions describe the environmental conditions necessary to ensure device safety, performance, and integrity.

Best practice tips

• Use numeric measurements wherever applicable. Include precise ranges (e.g. Store between 2–8°C, Humidity < 60% RH) to avoid ambiguity and ensure consistent interpretation across supply chain and clinical settings.
• Ensure each entry is unique and meaningful. When a device requires multiple storage and handling entries (e.g. temperature, humidity, pressure), make sure each value provides new, relevant information rather than repeating the same attribute.
• Use text only when necessary. The ‘Special storage instructions’ is appropriate to use only when the required storage and handling information is not available in the predefined list of storage and handling types. Keep the text clear and concise.
• Align with existing information. Ensure consistency with your product packaging.

Packaging

The Package Type field helps users understand the outer packaging of your device and allows them to understand the higher levels of packaging. 

Packaging information is mandatory if the device has higher levels of packaging.

Best practice tips

• Specify the package type.
• Include quantity per package. Indicate how many units are contained in each packaging configuration.
• Include all applicable packaging levels. If your device has multiple levels of packaging (i.e. base package, secondary package, tertiary package) include details for every level.
• Align with logistics systems. Ensure your packaging descriptions match ordering systems where possible.

For single use and restricted number of reuses

The Restricted Number of Reuses field allows you to include information on how many times a device can be safely reused. If your device is reusable but does not have a defined reuse limit - such as capital equipment - enter ‘N/A’ in the ‘For Single Use?’ field. This indicates that ‘Restricted Number of Reuses’ field is not applicable to your device.

Best practice tips

• Be precise. Include the specific maximum number of safe reuses.
• Do not include arbitrary numbers. If your device does not have a defined reuse limit, answer ‘N/A’ in the ‘For Single Use?’ field.

Supporting documents

The AusUDID allows you to add supporting documents such as:

• Patient Information Leaflets (PILs)
• Instructions for Use (IFUs).

Best practice tips

• Use current versions. Ensure your documents are up to date and match the model of device.
• Format for accessibility. Upload accessible PDFs or link to an accessible website.
• Use a URL to ensure your PILs or IFUs are kept up to date.