We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Acronyms and glossary terms
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.
Definitions
| Accessory | Accessory means a thing 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. |
| Alphanumeric | Consisting of both letters and numbers and often other symbols (such as punctuation marks and mathematical symbols). |
| AIDC | Automatic Identification and Data Capture (AIDC) refers to the methods of automatically identifying objects and entering them directly into computer systems without human involvement. AIDC technologies can include bar codes, QR codes, smart cards, biometrics and RFID. |
| API | Application Programming Interface (API) allows for 2 or more computer programs to communicate with each other. The Australian UDI Database uses an API for the Machine to Machine exchange of data. |
| APIM Credential | API Management Credentials (APIM Credentials) are the unique login credentials used when accessing the API Management Portal. These credentials are provided by the UDI Support Team upon request to use the Machine to Machine (M2M) method of UDI data submission in the Australian UDI Database (AusUDID). |
| APIM Portal | The API Management Portal (APIM Portal) which was established by the Department of Health and Aged Care to support Machine to Machine (M2M) data submission. The portal allows creation of API Subscription Keys and allows the user organisation to submit data to the Australian UDI Database (AusUDID) via HL7 SPL. |
| API Subscription Keys | API Subscription Keys are generated by an organisation within the APIM Portal. These keys can then be provided to another organisation or user registered within the APIM portal, such as a third-party data provider. API Subscription Keys allow a connection to be made between these organisations and enables the third-party data provider or user to utilise the APIM Portal to allow submission of UDI data to the Australian UDI Database (AusUDID). |
| AusUDID | The Australian Unique Device Identification Database (AusUDID), managed by the Therapeutic Goods Administration, stores UDIs and medical device data supplied by sponsors and manufacturers to identify models of device supplied in Australia. |
| Base package | The lowest packaging level. |
| Bulk Upload | A method of data submission to the Australian UDI Database via a Microsoft Excel Spreadsheet. |
| Configuration | Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together to provide an intended use or purpose as a medical device. The combination of items may be modified, adjusted or customised to meet a customer need. |
| Data delimiter | Within a UDI, a defined character or set of characters that specifies the boundary between specific data elements. These could also be called application identifiers or qualifying identifiers. |
| Device Classification | See Classification of medical devices. |
| Device Identifier (DI) | The term Device Identifier is synonymous with the proper technical term, UDI-DI. The UDI-DI is a unique numeric or alphanumeric code specific to a model of medical device. It is also used as the ‘access key’ to information stored in the AusUDID. |
| Direct Marking | Direct marking, for the purposes of UDI requirements, is recording the UDI permanently on the device itself. Reusable devices requiring reprocessing between uses must consider direct marking requirements. |
| Grace Period | The Grace Period is a set timeframe that begins once a UDI record has been published. During this timeframe, the UDI record can be edited without triggering a new UDI-DI or requiring a correction to be registered. |
| GDSN | Acronym for GS1 Global Data Synchronisation Network. For more information see Home - GS1 Australia. |
| GLN | Acronym for GS1 Global Location Number. For more information see Home - GS1 Australia. |
| GMDN | Global Medical Device Nomenclature (GMDN) is a collection of internationally recognised terms used to describe and catalogue medical devices, in particular, those products used in the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans. For more information see Home New - GMDN (gmdnagency.org). |
| GS1 | GS1 is one of 3 TGA recognised Issuing Agencies. |
| GTIN | Global Trade Item Number (GTIN) is the GS1 identification key used to identify trade items. For more information see Home - GS1 Australia. |
| HIBCC | Health Industry Business Communications Council (HIBCC) is one of 3 TGA recognised Issuing Agencies. For more information see HIBCC – Health Industry Business Communications Council. |
| HIBC-LIC | Health Industry Bar Code – Labeller Identification Code (HIBC-LIC) allows identification of a registered organisation of Issuing Agency Health Industry Business Communications Council (HIBCC). For more information see HIBCC – Health Industry Business Communications Council. |
| HIBC-UPN | Health Industry Bar Code – Universal Product Number is the HIBCC product identifier used to uniquely identify medical products. For more information see HIBCC – Health Industry Business Communications Council. |
| HL7 SPL | Health Level 7 Structured Product Labelling (HL7 SPL) is the format used in the Machine to Machine (M2M) method of data submission to the Australian UDI Database via an API connection. The Structured Product Labelling (SPL) specification is a document markup standard that specifies the structure and semantics of the content of authorised published information that accompanies a medical device licensed by a regulatory authority. HL7 SPL is managed by HL7 International. For more information see Health Level Seven International. |
| HRI | Human Readable Interpretation (HRI) is characters that can be read by people, e.g. letters and numbers, as opposed to symbol characters within barcode symbols, which are read by machines. |
| ICCBBA | The International Council for Commonality in Blood Banking Automation (ICCBBA) is one of 3 TGA recognised Issuing Agencies. For more information see ISBT 128 | ICCBBA. |
| ICCBBA ISBT 128-PPIC | The International Council for Commonality in Blood Banking Automation Information Standard for Blood and Transplant 128 - Processor Product Identification code is the ICCBBA product identifier used to uniquely identify products. For more information see ISBT 128 | ICCBBA. |
| eIFU | See Electronic Instructions for Use - eIFU. |
| 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. |
| Issuing Agency | An organisation that operates a system for the issuance and ensuring global uniqueness of UDIs. |
| 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 | Written, printed, or graphical information either appearing on the medical devices itself, or on the packaging of each unit, or on the packaging of a set or group of devices packaged together. |
| Mandatory compliance | Mandatory compliance refers to the time in which UDI requirements must be complied with, unless otherwise exempt. |
| 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. |
| M2M | Machine to Machine (M2M), is a method of data submission to the Australian UDI Database that uses the HL7 SPL format and the National Product Catalogue. M2M is the automated exchange of UDI data between computer systems without the manual intervention of humans. |
| NPC | National Product Catalogue (NPC) is one of GS1 Australia’s data pools in GS1’s Global Data Synchronisation Network (GDSN) services. This certified data pool is used to share master data between trading partners. NPC can be utilised within the Australian UDI Database as a method of data submission. |
| Own brand/private labeller | An Own Brand or Private Labeller relabels a device from a third part with their own name without making any further changes to the device, thereby taking responsibility as the manufacturer. |
| Packaging | Product to be used for the containment, protection, handling, delivery, storage, transport and presentation of goods, from raw materials to processed goods, from the producer to the user or consumer, including processor, assembler or other intermediary. |
| Packaging levels | Packaging levels refers to the various levels of device packages that contain a quantity of medical devices, for example a carton or case. Note: for the purpose of UDI, this does not include shipping containers or logistics units. |
| PIC | Patient Implant Card (PIC). For more information, see Patient implant cards and information leaflets. |
| PIL | Patient Information Leaflet (PIL). For more information, see Patient implant cards and information leaflets. |
| Previous DI | Previous Device Identifier (DI) is assigned to a version or model of a medical device prior to the assignment of a new device identifier to a medical device. This is required when a UDI is superseded due to a UDI Trigger. |
| Primary DI | The UDI-DI on the base package or the device itself is the Primary DI portion of the UDI that is submitted to the AusUDID. |
| Production Identifier (UDI-PI) | The Production Identifier is a numeric or alphanumeric code that describes the unit of device production. |
| RFID | Radio Frequency Identification (RFID) is a technology that uses communication through radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification. |
| Secondary DI | The Secondary DI is an optional data element in the UDI record designed to accommodate a DI from an Issuing Agency other than the Primary DI Issuing Agency. |
| Secondary package | Secondary packages contain a set number of base packages of a device. |
| Serial Number | A unique sequence of numbers or letter in a series used to identify an individual unit of a medical device. |
| Shipping containers/logistics units | Shipping container is a container whereby the traceability is controlled by a process specific to logistics systems. |
| SaMD | Software as a Medical Device (SaMD) is defined as software intended to be used for one or more medical purposes. |
| 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. |
| 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. |
| Standard | Document, established by consensus and approved by a recognised body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. |
| Tertiary package | Tertiary packages contain a set number of secondary packages of a device. |
| 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. |
| Unit of Use DI | The Unit of Use DI (UoU DI) is a virtual identifier assigned to an individual medical device. It is assigned in the instance when a UDI is not labelled at the level of device unit of use (for example, several units contained in a plastic bag). Its purpose is to associate the use of a device to or on a patient. |
| Unique Device Identifier (UDI) | A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters that is created through a globally accepted standard and applied to a specific model of medical device. It is comprised of both the UDI-DI and UDI-PI is applied to the device label and all applicable levels of packaging for the device in both AIDC and HRI. Note: the word ‘unique’ does not imply serialisation of individual production units. |
| Unique Device Identification system (UDI system) | A system that is intended to provide globally harmonised positive identification of medical devices through distribution and use. The system requires:
|
| UDI-DI | UDI-Device Identifier (UDI-DI) – identifies the model of medical device. The UDI-DI is used as the ‘access key’ to information stored in the AusUDID and will be used for device related information such as adverse events and recalls. Examples of the UDI-DI include a GS1 GTIN (Global Trade Item Number), a HIBC-UPN (Universal Product Number), or an ICCBBA ISBT 128-PPIC (Processor Product Identification Code). |
| UDI-PI | UDI-Production Identifier (UDI-PI) – identifies the production specific information such as the production run of the device. This could include a batch number, lot number or expiry date. The UDI-PI is present on the device but not stored in the Australian UDI Database (AusUDID). |
| UDI Carrier | The UDI Carrier is the means to convey the UDI by using AIDC and HRI. Note: Carriers can include 1D linear bar code, 2D or matrix bar code or RFID. |
| UDI Triggers | Changes to certain UDI data elements require a new UDI-DI to be allocated as they represent a change to the medical device that could lead to misidentification of the medical device or ambiguity in its traceability. These data elements are called UDI Triggers. |
| Voluntary compliance | Voluntary compliance refers to the time in which sponsors and manufacturers of medical devices may choose to comply with UDI requirements, prior to mandatory compliance. |