Glossary of Key Terms
Overview
Australian medical device regulation uses a defined set of technical terms that have specific legal meanings under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. Using these terms correctly — and understanding when a common word has a narrower legal meaning — is essential for anyone working in this space.
A
Accessory (to a medical device) A product that the manufacturer specifically intended to be used together with a medical device to enable or assist the device to function as intended by the manufacturer of the device. Accessories are regulated as medical devices in their own right. Source: Section 3(1), Therapeutic Goods Act 1989
Active implantable medical device (AIMD) A medical device that is intended to be totally or partially introduced into the human body or a natural orifice, and which is intended to remain there after the procedure, and which relies on a source of electrical energy or other source of power other than gravity or the human body. Examples include pacemakers and cochlear implants. Source: Schedule 2, Therapeutic Goods (Medical Devices) Regulations 2002
Active medical device A medical device that relies on a source of energy (other than energy directly generated by the human body or gravity) to function. Software is classified as an active medical device. Devices powered solely by gravity or directly by a human are not active devices. Source: Schedule 2, Therapeutic Goods (Medical Devices) Regulations 2002
ARTG (Australian Register of Therapeutic Goods) The official register of all therapeutic goods approved for supply in Australia. A medical device cannot generally be imported, supplied in, or exported from Australia unless it is included in the ARTG. The ARTG is publicly searchable. Source: Part 9-1, Therapeutic Goods Act 1989
ARTG entry A specific inclusion in the ARTG for a particular sponsor, manufacturer, and kind of medical device. Each combination requires its own ARTG entry.
C
Clinical evidence Scientific evidence that demonstrates a medical device performs as intended and meets the applicable Essential Principles, including the requirement that the benefits outweigh the risks. Clinical evidence may include clinical trial data, literature reviews, post-market surveillance data, and data from substantially equivalent devices. Source: Schedule 1, EP 14, Therapeutic Goods (Medical Devices) Regulations 2002
Comparable overseas regulator A regulatory authority in another country that has been accepted by the TGA as having regulatory requirements sufficiently comparable to Australia's. Evidence from these regulators (such as CE certificates from European notified bodies) may be used in place of, or to support, TGA conformity assessment. Comparable regulators include the US FDA, EU notified bodies, Health Canada, UK MHRA, and Singapore HSA, among others. Source: Regulation 5.3, Therapeutic Goods (Medical Devices) Regulations 2002
Conformity assessment The systematic and ongoing examination of evidence and procedures to determine that a medical device complies with the Essential Principles. The manufacturer is responsible for applying the appropriate conformity assessment procedures before the device is supplied. Source: Part 4-4, Therapeutic Goods Act 1989
Conformity Assessment Certificate A certificate issued by the TGA (or an Australian CAB or comparable overseas regulator) confirming that a manufacturer's quality management system and/or device design meets applicable requirements. Required for certain device classes as manufacturer evidence. Source: Part 4-4, Therapeutic Goods Act 1989
Custom-made device A device manufactured specifically in accordance with a written prescription for a named individual patient (or user). Custom-made devices are subject to specific exemptions and requirements under the MD Regulations. Source: Schedule 4, Therapeutic Goods (Medical Devices) Regulations 2002
D
Declaration of Conformity (Australian) A formal document prepared by the manufacturer stating which conformity assessment procedures have been applied to the device and that the device meets the Essential Principles. Required for all device classes; the level of evidence supporting the declaration increases with device class. Source: Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002
E
Essential Principles The fundamental safety and performance requirements that all medical devices supplied in Australia must meet. There are 6 general Essential Principles (applying to all devices) and 9 additional principles that apply on a case-by-case basis. The Essential Principles are set out in Schedule 1 of the MD Regulations. Source: Schedule 1, Therapeutic Goods (Medical Devices) Regulations 2002
I
IVD medical device (In vitro diagnostic medical device) A medical device — including a reagent, calibrator, control material, kit, specimen receptacle, or related instrument — intended to be used for the in vitro examination of specimens derived from the human body. IVDs are classified separately from other medical devices (Class 1–4) under Schedule 2A of the MD Regulations. Source: Therapeutic Goods (Medical Devices) Regulations 2002
IRIS (Incident Reporting and Investigation Scheme) The TGA's system for reporting adverse events involving medical devices. Sponsors are legally required to report adverse events through IRIS. Source: Part 4-9, Therapeutic Goods Act 1989
K
Kind of medical device The combination of features that define a specific medical device for ARTG purposes, including intended purpose, device classification, and key characteristics. Each kind of device requires its own ARTG entry. Source: Therapeutic Goods Act 1989 and MD Regulations
M
Manufacturer The person who designs, produces, fabricates, assembles, or processes a finished medical device and is responsible for placing it on the market under their own name, brand, or trademark. If a company relabels another manufacturer's device and supplies it under their own name, they become the manufacturer for regulatory purposes. Source: Section 41BG, Therapeutic Goods Act 1989
Manufacturer evidence Conformity assessment documentation that must be accepted by the TGA before an ARTG application for higher-class devices can proceed. For most devices above Class I, this includes a QMS certificate (ISO 13485 or equivalent) or a TGA Conformity Assessment Certificate, and/or evidence from a comparable overseas regulator. Source: Regulation 5.3, Therapeutic Goods (Medical Devices) Regulations 2002
Medical device An instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for a medical purpose (diagnosis, prevention, monitoring, treatment, alleviation of disease or injury, etc.) that generally achieves its purpose by physical, mechanical, or chemical means — not primarily by pharmacological, immunological, or metabolic means. Source: Section 41BD, Therapeutic Goods Act 1989
P
Post-market surveillance (PMS) The ongoing, systematic collection and analysis of data and information about a medical device after it has been placed on the market, to identify and act on any safety or performance issues. PMS is an ongoing obligation for all manufacturers.
Q
QMS (Quality Management System) A documented set of policies, processes, and procedures that a manufacturer uses to ensure consistent design, production, and post-market monitoring of medical devices. ISO 13485 is the internationally recognised standard for medical device QMS. Most Australian device classes require a certified QMS as part of conformity assessment.
S
Significant change A change to a medical device's design, intended purpose, materials, manufacturing process, or labelling that may affect the device's safety, performance, or classification. Significant changes may require notification to the TGA and potentially a new ARTG application or variation.
Sponsor The Australian-based individual or incorporated body that is legally responsible for the import into, export from, or supply of a medical device in Australia. Every device in the ARTG must have an Australian sponsor. Overseas manufacturers must appoint an Australian sponsor. Source: Section 3(1), Therapeutic Goods Act 1989
System or procedure pack A combination of products — which may include medical devices, medicines, or other items — packaged together by a person other than the original manufacturer, for a specific medical procedure. Systems and procedure packs have specific regulatory requirements under Section 41BF of the Act. Source: Section 41BF, Therapeutic Goods Act 1989
T
Technical file / Design dossier The compilation of documentation maintained by the manufacturer that demonstrates the device meets the Essential Principles. There is no mandated format in Australia — the IMDRF STED format and EU Technical Documentation formats are accepted.
TGA (Therapeutic Goods Administration) The regulatory agency of the Australian Government responsible for regulating the quality, safety, efficacy, and timely availability of therapeutic goods (including medical devices) in Australia. The TGA is part of the Department of Health, Disability and Ageing.
U
UDI (Unique Device Identification) A system of numeric or alphanumeric codes that enables the clear identification of specific medical devices and their versions or models. The TGA has introduced mandatory UDI requirements progressively, starting with higher-risk device classes. UDI information is submitted to the Australian UDI Database (AusUDID). Source: Therapeutic Goods (Medical Devices) Regulations 2002 — UDI provisions