What is a Medical Device?
Overview
In Australia, whether a product is a medical device is determined by its intended purpose — not by what it is made of or how it looks. A product is a medical device if the manufacturer intends it to achieve a medical outcome, generally through physical, mechanical, or chemical means. The formal definition sits in Section 41BD of the Therapeutic Goods Act 1989 and was updated in 2020 to explicitly include software, implants, and reagents. If your product meets this definition, it must generally be included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally supplied in Australia.
The Legal Definition
Under Section 41BD, a medical device is an instrument, apparatus, appliance, software, implant, reagent, material or other article that is intended by its manufacturer to be used for one or more of the following purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease
- Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- Investigation, replacement, modification or support of the anatomy or a physiological process
- Supporting or sustaining life
- Control or support of conception
- Disinfection of another medical device
- Providing information through in vitro examination of specimens taken from the human body
A medical device generally achieves its purpose through physical, mechanical, or chemical action — not primarily through pharmacological, immunological, or metabolic means. Products that work primarily through those biological mechanisms are generally regulated as medicines, not medical devices.
Why Intended Purpose Matters
The intended purpose is what determines whether a product is a medical device — and what class it falls into. The TGA determines intended purpose from what the manufacturer states or implies, including through:
- Labelling and instructions for use
- Promotional materials and advertising
- Technical documentation and clinical claims
The same physical product can be a medical device or not depending on how it is labelled and what claims are made. A pair of gloves marketed as sterile surgical gloves is a medical device. The same gloves sold only as general workwear protective equipment may not be. Manufacturers are responsible for accurately declaring the intended purpose.
IVD Medical Devices
In vitro diagnostic (IVD) medical devices are a regulated subset used to examine specimens — such as blood, urine, or tissue — outside the body. Examples include blood glucose monitors, pregnancy tests, and COVID-19 rapid antigen tests. IVDs are defined separately in the Therapeutic Goods (Medical Devices) Regulations 2002 and have their own classification system (Class 1–4) but sit within the same overall regulatory framework.
Accessories to Medical Devices
An accessory is a product the manufacturer specifically intended to be used together with a medical device to enable or assist it to function as intended. Accessories are regulated as medical devices in their own right and require a separate ARTG entry.
Who This Applies To
| Role | Why it matters |
|---|---|
| Manufacturer | You are responsible for determining whether your product meets the definition and for declaring its intended purpose accurately |
| Sponsor | You must ensure any device you apply to include in the ARTG genuinely meets the definition |
| Importer | Importing a product that meets the definition without ARTG inclusion may be an offence under the Act |
| Consultant / Auditor | The definition is the starting point for any regulatory assessment or classification exercise |
Not Sure if Your Product is a Medical Device?
The TGA provides an interactive decision tool:
👉 Is my product a medical device? — TGA Decision Tool
Official Sources
- Section 41BD — Therapeutic Goods Act 1989
- Overview of medical devices and IVD regulation — TGA
- Understanding medical device definitions — TGA guidance
- Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020