Before you can supply a medical device in Australia, you need to know its class. The class decides what evidence the manufacturer must hold, how the Therapeutic Goods Administration (TGA) treats your application to the Australian Register of Therapeutic Goods (ARTG), whether an application audit is likely, and which government fees and annual charges you pay. Get the class wrong and the whole application can go wrong with it.
This guide explains how classification works under the TGA’s rules, what changes between Class I, IIa, IIb and III, and the Class I details (sterile and measuring devices) that often catch importers out. We use only the TGA’s own examples. We do not classify any particular product here, because the class always depends on that product’s intended purpose.
This post is general information, not legal or regulatory advice. Always confirm the current rules with the TGA before you apply.
Who decides the class, and on what basis?
Under Australian law the manufacturer is responsible for classifying a medical device. The sponsor, the Australian business that applies to include the device in the ARTG, must enter the correct class in the application. The TGA states that it cannot refund application fees for applications entered with the wrong class.
Classification is based on the device’s intended purpose. The TGA says this is the purpose stated in the manufacturer’s:
- instructions for use (IFU)
- labels
- advertising materials
- technical documents that describe how the device works.
This has a practical consequence the TGA spells out: identical devices can have different classes if they are intended to be used in different ways, for example in different parts of the body, by health professionals or by consumers, or with other devices. The TGA also notes that Australian classification rules can differ from overseas rules, so a class assigned in another country is not automatically the Australian class.
The legal framework in brief
Classification comes from two pieces of legislation:
- Therapeutic Goods Act 1989: section 41BD(2) (intended purpose) and section 41DB (medical device classifications).
- Therapeutic Goods (Medical Devices) Regulations 2002: regulation 3.1 sets out the classes, regulations 3.2 and 3.3 set out the classification principles, Schedule 2 contains the rules for devices other than in vitro diagnostic (IVD) devices, Schedule 2A contains the IVD rules, and the Dictionary defines key terms.
Regulation 3.1 lists four classes for devices other than IVDs, from lowest to highest: Class I, Class IIa, Class IIb and Class III. IVD devices use a separate scale, Class 1 to Class 4.
The classification principles
Before you apply any individual rule, regulation 3.3 sets some ground rules:
- Highest class wins. If two or more rules apply to a device, it takes the highest class from those rules. The TGA gives the example of a device used in surgery that depends on a source of energy, which is covered by both the invasive and the active device rules.
- Most critical use. If a device is not designed for use solely or mainly in one part of the body, it is classified by its most critical specified use. The TGA’s example is a catheter: for short-term use in peripheral arteries it is Class IIa; for use in the central circulatory system it is Class III; if the manufacturer intends it for both, it is Class III.
- Separate classification. Devices designed to be used together are each classified separately, and an accessory is classified separately from the device it is used with.
- Software follows the device. If a device is driven or influenced by software, the software has the same class as the device. The TGA notes that this includes apps on a phone or tablet that drive a device.
How the rules are organised
Schedule 2 groups its rules by how the device interacts with the body. The TGA’s guidance on classifying medical devices that are not IVDs and on classifying active medical devices explains each group. In short, the rules look at:
- Invasiveness. Non-invasive devices do not penetrate the body. Invasive devices enter a body orifice, penetrate the body surface or are used in surgery. The TGA notes that a device touching the surface of the eye, such as a contact lens, counts as being in a body orifice.
- Duration of use. Transient use is a continuous period of less than 60 minutes, short-term is 60 minutes to 30 days, and long-term is more than 30 days.
- Location. Devices in direct contact with the heart, central circulatory system or central nervous system generally sit in higher classes.
- Energy source. Active devices rely on a source of energy other than the human body or gravity, and have their own rules.
- Special rules. Some features push a device up, such as containing a medicine, or tissues, cells or substances of animal, biological or microbiological origin.
An official example: wound dressings
The TGA’s decision tool shows how one product type can fall into four classes depending on intended purpose. For non-invasive devices in contact with injured skin:
- a mechanical barrier, compression or absorption of exudate, not supplied sterile: Class I
- the same purpose, supplied sterile: Class I sterile (Class Is)
- managing the micro-environment of a wound, for example keeping it moist: Class IIa
- use on wounds that have breached the dermis and can only heal by secondary intent: Class IIb.
The TGA’s guidance gives a second example from the invasive rules. Under sub-rule 3.2, a reusable surgical instrument such as scissors or artery forceps is Class I, a surgically invasive device for transient use such as a hypodermic needle or syringe is Class IIa, and a cardiovascular catheter used to diagnose, monitor or correct a defect of the heart or central circulatory system through direct contact is Class III.
Class I, IIa, IIb and III at a glance
The TGA describes the classes by level of potential harm and gives these examples on its regulation overview page:
Table 1: Device classes, risk and TGA examples
| Class | TGA risk level | TGA examples |
|---|---|---|
| Class I | Lowest / low | Surgical retractors, tongue depressors |
| Class I supplied sterile (Is), Class I with a measuring function (Im), Class IIa | Low to low–moderate | Hypodermic needles, suction unit; medicine cup with specific units of measurement; digital or infrared thermometers |
| Class IIb | Moderate to high | Lung ventilator, blood bags, condoms |
| Class III | High | Heart valves, major joint replacement implants, devices containing medicines or tissues, cells or substances of animal, biological or microbiological origin; implantable defibrillators (formerly AIMD) |
Sources: TGA, Overview of medical devices and IVD regulation; TGA, What classification is my medical device? (risk levels). The TGA groups these examples by risk band rather than by single class, so check the rules for each device.
How the class changes your evidence
The higher the class, the more the manufacturer must do to show the device meets the Essential Principles, the TGA’s safety and performance requirements. This proof is called conformity assessment evidence.
- Class I (non-sterile, non-measuring): the manufacturer can rely on its own signed Declaration of Conformity. The sponsor uploads it with the ARTG application. The TGA warns that giving false or misleading information in this declaration is a serious offence.
- All other classes: the TGA says conformity assessment documentation must be issued by a third-party, independent body. What is acceptable depends on the class and on which body assessed the device, for example a TGA conformity assessment certificate or evidence from a comparable overseas regulator.
Class also affects application audits. After a 2024 amendment to regulation 5.3, mandatory audits are limited to some higher-risk applications. For non-IVD devices, the TGA lists Class III applications supported by European Union Medical Devices Directive (MDD) certificates, UK approved body certificates or US 510(k) evidence. The TGA can still select other applications for audit, for example when it has concerns about the information provided or about the device. Our guide to the TGA medical device approval process walks through the steps from evidence to ARTG inclusion.
Class I nuances: sterile and measuring devices
Class I is not one simple category. Regulation 3.9 creates two important sub-groups:
- Class I supplied sterile (Is). If the manufacturer intends the device to be supplied sterile, the Declaration of Conformity is not enough on its own. The manufacturer must also apply production quality assurance procedures. The TGA defines a device as “supplied sterile” if it is sterilised before the manufacturer releases it.
- Class I with a measuring function (Im). If the device has a measuring function, the manufacturer must also apply one of the verification, production quality assurance or product quality assurance procedures. Under regulation 1.4, a device has a measuring function if the manufacturer intends it to measure a physiological or anatomical parameter quantitatively, or to measure the quantity or a qualifiable characteristic of energy or substances delivered to or removed from the body. The TGA’s example is a medicine cup with specific units of measurement.
The TGA’s Declaration of Conformity guidance therefore applies only to Class I non-sterile, non-measuring devices (along with Class 1 IVDs, export-only Class I devices and Class I systems and procedure packs). If your Class I device is sterile or measures something, plan for third-party evidence covering those aspects.
If a supplier tells you a product is “just Class I”, ask whether it is supplied sterile or has a measuring function. The answer changes the evidence you need and, as our fees guide shows, the annual charge.
How the class changes your fees
TGA application fees, audit fees and annual charges are set by class. Higher-class devices pay more to apply and more each year to stay on the ARTG, and sterile or measuring Class I devices pay a higher annual charge than other Class I devices. We keep the current figures in one place: see How much does TGA approval cost? 2026–27 fees.
A note on AIMD
Active implantable medical devices (AIMD), such as pacemakers, used to be a separate class. AIMD is now Class III. Older documents may still say AIMD. The change took effect on 25 November 2021 under rule 5.7 of Schedule 2. Implantable accessories to AIMDs, such as pacemaker leads, and active devices used to control, monitor or directly influence an AIMD, such as a clinician’s pacemaker programmer, are also Class III.
Reclassification reforms with a 2029 deadline
On 25 November 2021, the TGA reclassified several device groups upwards: active medical devices for therapy with a diagnostic function; motion-preserving spinal implantable devices; devices in direct contact with the heart, central circulatory system or central nervous system; devices that administer medicines or biologicals by inhalation; and devices that are substances introduced into the body via a body orifice or applied to the skin (each including related software). For existing ARTG entries that were notified to the TGA by 25 May 2022, the transition deadline to apply at the new class is 1 July 2029. If you sponsor a device in one of these groups, check that it is on track.
Software as a medical device
Since 25 February 2021, software-based medical devices have had their own classification rules, based on the harm that incorrect information could cause. For example, under rule 4.5 software that gives a diagnosis or screening result directly is classed higher than software that only supports a relevant health professional’s decision, and the class also depends on how serious the disease or condition is. Transition for existing ARTG entries ended on 1 November 2024. These rules do not apply to IVDs.
We cover software in more depth in our post on the TGA’s approach to regulating software as a medical device.
IVDs are classified differently
In vitro diagnostic devices, which test samples taken from the body such as blood or urine, do not use Class I to III. They use Class 1 to Class 4 under Schedule 2A, based on the personal and public health risk of an incorrect result. Our separate guide to IVD classification and ARTG inclusion in Australia covers these rules.
Common classification mistakes
- Copying the overseas class. The TGA states that Australian rules can differ from overseas rules. Classify against Schedule 2.
- Claims that change the intended purpose. Because intended purpose includes labels and advertising, a new claim can move a device into a higher class.
- Forgetting accessories and combined devices. Each is classified separately.
- Missing the sterile or measuring step. A Class I device that is sterile or measures something needs more than a Declaration of Conformity.
- Not reviewing the class after a change. The TGA’s active device guidance advises reviewing the class when the intended purpose, functions or claims change.
Next steps
Start with the TGA’s free What classification is my medical device? tool, then check the result against the rules in Schedule 2 and the TGA guidance linked above. Have the manufacturer’s IFU, labels and marketing material in front of you, because they define the intended purpose.
If your device sits near a class boundary, or you rely on overseas evidence, a classification review before you lodge can save a refused application and a non-refundable fee. Our medical devices page explains how R2 Pharma Solutions supports sponsors and manufacturers.
Want a second opinion on your device’s class and evidence? Contact us for a quote.