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We use these terms, definitions and acronyms in the regulation of therapeutic goods in Australia in relation to the Unique Device Identification (UDI) system.
We have provided this list is provided as general information only. This list is not exhaustive.
You can find the general Therapeutic Goods Administration glossary here: Acronyms and glossary terms.
You can find information specific to Australian UDI data elements in the Australian UDI Data Dictionary.
Definitions
| Term | Definition |
| Accessory | A product intended specifically by its manufacturer to be used together with a specific medical device(s) to enable the medical device to be used in accordance with its intended use. |
| Adaptable medical device | See Understanding personalised medical devices rules (including 3D-printed devices) |
| Alphanumeric | Consisting of letters and numbers and may include additional symbols such as mathematical signs or punctuation marks. |
| Application Programming Interface (API) | A defined set of protocols and tools that enables communication and data exchange between software applications. |
| API Management Credential (APIM Credential) | Authentication details issued for secure access to the API Management Portal for machine-to-machine data submission. |
| API Management Portal (APIM Portal) | A secure platform provided by the Department of Health, Disability and Ageing for managing API keys and facilitating UDI record submission to the AusUDID. |
| API Subscription Key | Unique identifiers generated within the API Management Portal to authorise data exchange between registered entities. |
| Australian Register of Therapeutic Goods (ARTG) | The official register of therapeutic goods that can be lawfully supplied in Australia. UDI records in the AusUDID link to ARTG inclusions. See About the Australian Register of Therapeutic Goods (ARTG) |
| Australian Unique Device Identification Database (AusUDID) | A centralised database maintained by the Therapeutic Goods Administration (TGA) for storing UDI records. See TGA AusUDID |
| AusUDID Pre-Production environment | The testing environment for sponsors and manufactures to validate UDI record submissions before using the AusUDID Production environment. |
| AusUDID Production environment | The live environment where official UDI records are stored and accessed. Referred to as the AusUDID. |
| Automatic Identification and Data Capture (AIDC) | Technologies that enable automatic identification of objects and direct data entry into computer systems without manual intervention, including barcodes, QR codes, and RFID. |
| Base package | The lowest level of packaging that directly contains a medical device. |
| Bulk Upload | A data submission method using the Australian UDI Bulk Upload Template that allows submission of multiple UDI records simultaneously. |
| Client ID | A unique identifier used for authenticating API submissions. |
| Compliance date | The date by which UDI requirements must be met. |
| Conditionally mandatory data element | Data elements that are mandatory when other data elements have been provided or a device is a certain type of device. |
| Configuration | A manufacturer-defined combination of items that operate together to fulfill a specific medical purpose. |
| Custom-made medical device | See Understanding personalised medical devices rules (including 3D-printed devices) |
| Data delimiter | A character or sequence of characters used within the HRI portion of a UDI to separate distinct data elements. |
| Data validation | Criteria used to confirm the accuracy and completeness of UDI record submissions. |
| Devices principally sold in retail premises | Devices that are principally intended for sale in retail premises such as supermarkets. |
| Device risk classification | A categorisation of medical devices based on risk, as defined under regulatory frameworks. |
| Direct marking | The permanent application of a UDI directly onto the device surface, typically required for reusable devices. |
| Direct Marking DI | The UDI that is directly marked onto a device itself. |
| Drafter | A role in the AusUDID that allows users to draft UDI records. The AusUDID leverages the existing TBS roles. |
| Electronic Instructions for Use (eIFU) | Digitally accessible Instructions for Use provided in lieu of printed documentation for medical devices. See Supplying electronic instructions for use (eIFU) for medical devices |
| EU MDD to EU MDR transitional arrangement | A transitional arrangement available for certain devices. See Complying with the Unique Device Identification timeframes for medical devices |
| EU IVDD to EU IVDR transitional arrangement | A transitional arrangement available for certain devices. See Complying with the Unique Device Identification timeframes for medical devices |
| Existing devices | Devices that are manufactured and labelled before their compliance date. |
| Existing devices transitional arrangement | A transitional arrangement available for certain devices. See Complying with the Unique Device Identification timeframes for medical devices |
| Global Location Number (GLN) | A GS1 identification key that uniquely identifies physical locations or legal entities. See GS1 Australia |
| Global Medical Device Nomenclature (GMDN) | A standardised system of internationally recognised terms for describing medical devices. See GMDN |
| Global Trade Item Number (GTIN) | A GS1 identification key used to uniquely identify trade items. A GTIN may be used as a UDI-DI. See GS1 Australia |
| Grace Period | The period of time after a UDI record is submitted in which any changes can be made to a UDI record without requiring a correction or a new UDI-DI. |
| GS1 | An international organisation recognised by the TGA as an Issuing Agency. See GS1 Australia |
| Health Industry Bar Code – Labeller Identification Code (HIBC-LIC) | A code that identifies organisations registered with the Health Industry Business Communications Council. |
| Health Industry Bar Code – Universal Product Number (HIBC-UPN) | A product identifier issued by HIBCC for unique identification of medical devices. A HIBC-UPN may be used as a UDI-DI. |
| Health Industry Business Communications Council (HIBCC) | An international organisation recognised by the TGA as an Issuing Agency. |
| Health Level 7 Structured Product Labelling (HL7 SPL) | Health Level 7 Structured Product Labelling (HL7 SPL) is the format used in the Machine to Machine method of data submission to the Australian UDI Database via an API connection. See: Health Level Seven International and Submitting UDI records using HL7 SPL |
| Human Readable Interpretation (HRI) | The representation of encoded data in a format that can be read by humans. |
| ICCBBA ISBT 128 Processor Product Identification Code (ICCBBA ISBT 128-PPIC) | A unique identifier for blood and transplant products issued under the ISBT 128 standard. An ICCBBA ISBT 128-PPIC may be used as a UDI-DI. See ISBT 128 |
| International Council for Commonality in Blood Banking Automation (ICCBBA) | An international organisation recognised by the TGA as an Issuing Agency. See ISBT 128 |
| International Medical Device Regulators Forum (IMDRF) | A global group that develops harmonised regulatory guidance for medical devices. |
| Implantable device | Any device, including those that are partially or wholly absorbed, which is intended to either:
by surgical intervention which is intended to remain in place after the procedure. |
| In vitro diagnostic (IVD) medical device | Devices intended for the examination of specimens derived from the human body. |
| Issuing Agency | An entity authorised to allocate UDI-DIs and ensure their global uniqueness. |
| Kits | Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and are being distributed as medical devices. These could also be called procedure packs or convenience kits. |
| Label | Printed, written, or graphical information affixed to a medical device or its packaging. |
| Machine to Machine | Automated data exchange between computer systems without human intervention. |
| Mandatory compliance | The date from which adherence to UDI requirements becomes legally enforceable. See Complying with the Unique Device Identification timeframes for medical devices |
| Mandatory data element | Data elements that are mandatory and must be included in a UDI record. |
| Manufacturer | Corporation or person carrying out one or more of the steps specified in the definition of manufacture. Section 41BG in Part 4-1 Division 2 of the Therapeutic Goods Act 1989 contains a full definition. |
| Medical device | Articles intended for use in diagnosis, prevention, monitoring, or treatment of disease or injury. |
| National Product Catalogue (NPC) | A GS1-certified data pool used for sharing standardised product information among trading partners. The NPC can be used to submit UDI records to the AusUDID. |
| Optional data element | Data elements that can be included in a UDI record on a voluntary basis. |
| Own brand or private labeller | An entity that rebrands a medical device without altering its design, assuming manufacturer responsibilities. |
| Package Device Identifier | The UDI-DI assigned to a specific packaging level above the base package, such as secondary or tertiary packaging. |
| Packaging | Materials used to contain, protect, and present goods during handling, storage, and transport. |
| Packaging levels | Hierarchical layers of packaging for medical devices. Note that logistics units or shipping contains are not in scope of UDI requirements. |
| Patient Implant Cards (PICs) | A card provided to patients containing essential information about an implanted device. |
| Patient Information Leaflet (PIL) | A document supplied to patients detailing the safe use of a medical device. |
| Patient Matched Medical Device | See Understanding personalised medical devices rules (including 3D-printed devices) |
| Primary DI | The UDI-DI of the base package is included in the AusUDID as the Primary DI. It is the main lookup value for UDI records. |
| Radio Frequency Identification (RFID) | A technology that uses electromagnetic fields to automatically identify and track tags attached to objects. |
| Secondary package | A packaging level that contains multiple base packages |
| Secret | A security token used for authenticating UDI record submissions. |
| Shipping container or logistics unit | Packaging units managed within logistics systems for transportation. |
| Software as a Medical Device (SaMD) | Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes. See Understanding regulation of software-based medical devices |
| Sponsor | In relation to therapeutic goods, means:
But does not include:
A full definition is provided in Chapter 1 Section 3 of the Therapeutic Goods Act 1989. |
| Submitter | A role in the AusUDID that allows users to draft and submit UDI records. The AusUDID leverages the existing TBS roles. |
| System or Procedure Packs (SOPPs) | System or Procedure Packs (SOPPs) are medical devices intended to be used in a medical or surgical procedure, containing a combination of 2 or more goods where at least one of the goods is a medical device or in vitro diagnostic device, and all goods are packaged together or are to be interconnected or combined for use. See Understanding medical device definitions and rules for system or procedure packs |
| Tertiary package | A packaging level that contains secondary packages. |
| TGA Business Services (TBS) | The portal used by sponsors and manufacturers to access the AusUDID and other TGA systems. |
| Therapeutic Goods Administration (TGA) | The Australian Government authority responsible for regulating therapeutic goods, including medical devices. See About us |
| Third party | A third party, for the purpose of UDI, is a company or individual other than the sponsor or manufacturer of a device that, based on a contract with that sponsor or manufacturer, is authorised by the sponsor or manufacturer to carry out certain operations on their behalf such as submitting data to the AusUDID or placed the UDI Carrier on the device. |
| UDI Carrier | The medium used to convey they UDI, including both the HRI and AIDC forms. |
| UDI Device Identifier (UDI-DI) | The portion of the UDI that uniquely identifies the device model. |
| UDI Production Identifier (UDI-PI) | The portion of the UDI that identifies production-specific details. |
| UDI Mailing List | A TGA managed subscription service for receiving updates and notifications related to the Australian UDI system and the AusUDID. |
| UDI record | A structed set of data elements submitted to the AusUDID by a sponsor or manufacturer, including the UDI-DI and related data. |
| UDI Trigger | Changes to device attributes that necessitate assignment of a new UDI-DI. |
| Unique Device Identifier (UDI) | A globally unique numeric or alphanumeric code that uniquely identifies a medical device model and production run. |
| Unique Device Identification system | A system designed to ensure global identification of medical devices through labelling and a UDI database. |
| Voluntary compliance | The period during which manufacturers may choose to comply with UDI requirements before mandatory enforcement. See Complying with the Unique Device Identification timeframes for medical devices |