Dental clinics use a huge range of products, from handheld mirrors and impression materials to restorative materials, implants and powered equipment. In Australia, many of these products are regulated as medical devices. Unless a device is exempt or excluded, it must be included in the Australian Register of Therapeutic Goods (ARTG) before it can be legally supplied, and the Therapeutic Goods Administration (TGA) holds the sponsor responsible for getting it there.
This guide is for Australian importers, distributors and manufacturers who want to bring dental devices to market. It explains which dental products are regulated as medical devices, how the class of a device shapes the pathway, the evidence the TGA expects, the steps for an ARTG application, and the labelling and advertising rules that apply once you are on the market. We also cover, briefly, when a dentist or dental laboratory becomes a sponsor. We do not classify any particular brand or product here, because the class always depends on the manufacturer’s intended purpose.
This post is general information, not legal or regulatory advice. Always confirm the current rules with the TGA before you import, supply or apply.
Which dental products are medical devices?
The TGA describes a medical device as any product or software (including AI) that the supplier intends to be used for a therapeutic purpose in or on human beings, and that does not achieve its main intended action by pharmacological, immunological or metabolic means. The TGA’s own examples of medical devices include medical gloves, syringes and X-ray equipment.
For the dental sector, the TGA’s guidance says that, unless exempt, ARTG inclusion is required for:
- Mass-produced dental devices.
- Adaptable medical devices. Devices made so that they can be personalised to fit a patient after they are supplied.
- Specified materials and components. Materials and components that are declared to be medical devices and are intended to be used to make a non-implantable dental device in a practice. The TGA lists materials for direct and indirect tooth restoration among these “specified articles”, for example amalgam, composite resins and bonding systems, glass ionomers, fissure sealants, ceramics, metal alloys and temporary crown or bridge materials.
Implantable dental devices, such as dental implants, implant abutments and temporary anchorage devices (for example mini screws), must also be included in the ARTG before they are imported or supplied, subject to the transitional arrangements for patient-matched devices described below.
If you are new to device regulation more generally, our medical devices page gives an overview of how R2 Pharma Solutions supports sponsors.
Who is the sponsor?
Under the TGA’s definition, a sponsor is the person who imports goods into Australia, exports them, or manufactures them in Australia (or arranges for any of these). The sponsor is the party that applies for ARTG inclusion.
Two points often surprise importers:
- Each ARTG entry belongs to one sponsor. An entry is unique to the sponsor, the manufacturer and the kind of device. Every sponsor must apply for its own imported devices, even if another sponsor already has an ARTG entry for the same device.
- Inclusion is the start, not the end. Sponsors must keep the device compliant with the law while it is on the market, keep records of the devices they supply, report adverse events and problems, and take corrective action such as recalls when needed.
Before you sign a distribution agreement, check with the overseas manufacturer who will be the Australian sponsor, and who will hold the technical documentation the TGA may ask to see.
Dentists and dental laboratories: when you become a sponsor
The TGA’s dental guidance explains that a registered dental practitioner takes on sponsor responsibilities when they import dental devices, and takes on manufacturer and sponsor responsibilities when they make dental devices away from the chair-side. If you buy finished devices from a sponsor who has already included them in the ARTG, or finished exempt devices from a sponsor, you are not the sponsor and do not need to apply.
For personalised dental devices, the key exemptions are:
- Patient-matched medical devices (PMMDs). PMMDs are exempt from ARTG inclusion under a transitional arrangement until 1 July 2029. After that date they must be included in the ARTG before supply, unless another exemption applies.
- Specified articles exemption. A health professional who makes non-implantable dental devices or tooth restorations exclusively from ARTG-included materials or components (or a person working to their written instructions) does not have to include the finished devices in the ARTG. This exemption does not cover materials used to make implantable dental devices.
- Low-volume exemption. The first 5 PMMDs of a “kind” supplied by one entity in a financial year are exempt from ARTG inclusion. This exemption continues after 1 July 2029.
Exempt does not mean unregulated. Exempt devices must still meet the Essential Principles (including labelling and instructions for use), the advertising rules and adverse event reporting. See the TGA’s guidance for dental practitioners and its personalised medical devices pages for the detail.
Classification: the framework for dental devices
Medical devices that are not in vitro diagnostic (IVD) devices fall into Class I, Class IIa, Class IIb and Class III, from lowest to highest risk. Class I also has two special sub-groups: Class Is (supplied sterile) and Class Im (with a measuring function). The higher the class, the more regulatory evidence the manufacturer must hold.
The class depends on the manufacturer’s intended purpose, not on what a similar product is called. Most dental devices are invasive because they enter the body through the mouth, so the TGA’s rule for devices that enter a body orifice (sub-rule 3.1) is often the starting point. Under that rule, the class turns on:
- How long the device is used: transient, short-term or long-term use.
- Where it is used: the rule treats devices used only in the oral cavity as far as the pharynx differently from devices used elsewhere.
- Whether it connects to an active device: an invasive device connected to an active device of Class IIa or higher is at least Class IIa.
The TGA’s guidance gives a few clear Class I dental examples: handheld dental mirrors and dental impression materials (invasive devices not connected to an active device), and dental bite registration wax (short-term use in the oral cavity).
Other rules can also apply. Surgically invasive and implantable devices, active (powered) equipment and software have their own rules. Where more than one rule applies, the highest resulting class is the correct one. Where a device has more than one intended purpose, the purpose with the highest class decides.
For a full walk-through of the rules, see our guide to medical device classification in Australia, and the TGA’s classification decision tool.
Ask the manufacturer for the Australian class and the rule they relied on, in writing, before you budget for the application. A class that matches the EU or US class is not automatically the Australian class.
Conformity assessment and the evidence you need
Every device supplied in Australia must comply with the Essential Principles for safety and performance in the Therapeutic Goods (Medical Devices) Regulations 2002. The manufacturer shows this by applying a conformity assessment procedure suited to the class of the device. Before the sponsor can apply for ARTG inclusion, the manufacturer must hold the right evidence.
Manufacturer Evidence
For most devices, the sponsor first lodges the manufacturer’s conformity assessment documents as a Manufacturer Evidence application in the TGA Business Services (TBS) portal. The TGA aims to process these within 15 working days, and there is no fee for this step. Once accepted, the evidence gets an identifier that you link to your ARTG application. The TGA advises not to start the inclusion application until you are notified that the evidence has been accepted.
Depending on the class, acceptable Manufacturer Evidence includes:
- a TGA conformity assessment certificate
- market authorisation or conformity assessment evidence from a comparable overseas regulator
- a declaration of conformity for a system or procedure pack.
Class I non-sterile, non-measuring devices do not need a Manufacturer Evidence application. Instead, the manufacturer’s Declaration of Conformity is attached to the ARTG application. The TGA can ask for further documents, such as labels and instructions for use, at any time after inclusion.
Using overseas approvals
The TGA relies on certain overseas approvals, set out in its guidance on comparable overseas regulators (version 2.1, April 2026). These include certificates from European Union notified bodies, United States Food and Drug Administration (FDA) 510(k) and premarket approval decisions, Health Canada licences, Japanese pre-market approvals, Singapore Health Sciences Authority registrations, United Kingdom approved body certificates and Medical Device Single Audit Program (MDSAP) certificates. MDSAP evidence counts only if the audits covered Australian requirements.
The overseas evidence must relate to the same device, with the same design, intended purpose, intended user and indications. Table 2 of that guidance lists the documents that must be attached to an inclusion application for each class. If they are missing, the application will not pass preliminary assessment and will be refused.
The Declaration of Conformity must be made under the Australian requirements. The TGA says, for example, that a declaration made to the European Medical Devices Directive is not acceptable.
ARTG inclusion: the steps for sponsors
1. Confirm that it is a medical device. Check the intended purpose and whether any exemption or exclusion applies.
2. Confirm the class. Get the class, and the rule it was based on, from the manufacturer.
3. Set up access. Get a TGA Business Services account if you do not already have one.
4. Gather the evidence. Collect the conformity assessment documents, the Australian Declaration of Conformity and any documents that Table 2 requires for the class.
5. Lodge the Manufacturer Evidence (if required). Wait for acceptance before you continue.
6. Lodge the inclusion application. Enter the device details using information from the manufacturer, including the Global Medical Device Nomenclature (GMDN) code, and pay the application fee shown for the class.
7. Preliminary assessment and possible audit. The TGA checks the application. It may select it for an application audit, for example where the kind of device is prescribed in the regulations, or where there are concerns about the information or the device’s safety.
8. Inclusion and ongoing obligations. Once included, you can supply the device, and your post-market duties begin.
Our article on the TGA medical device approval process goes through these stages in more detail. For government application fees, audit fees and annual charges, see our guide to TGA approval costs and fees.
Labelling and advertising basics
Labels and instructions
Essential Principle 13 sets out the information that must come with a medical device. It includes:
- the manufacturer’s name (or trading name) and address
- the intended use, user and patient, if these are not obvious
- enough information to identify the device or packaging contents
- handling or storage requirements, warnings, restrictions and precautions
- a single-use indication, where applicable
- for sterile devices, the word “STERILE” and the sterilisation method
- the batch code, lot number or serial number
- a use-by date (month and year) where applicable, or otherwise the date of manufacture.
Information can appear in more than one language, but if the device is supplied in Australia, one of those languages must be English. Relabelling a device under the manufacturer’s instructions does not make a sponsor the manufacturer. See the TGA’s labelling guidance for the full list.
Unique Device Identification
Unique Device Identification (UDI) requirements began on 1 July 2026, starting with higher-risk devices. The TGA says dental devices must meet UDI requirements where the sponsor’s device is in scope. Class Is, IIa, IIb and III devices are in scope. Class I non-sterile, non-measuring devices and Class Im devices are not, although manufacturers can choose to apply a UDI. Check the TGA’s UDI hub for the dates and exemptions that apply to your device.
Advertising
Advertising of medical devices is governed by the Therapeutic Goods Act 1989, the Therapeutic Goods Advertising Code and other laws, including the Competition and Consumer Act 2010. The TGA treats advertising broadly. It can include statements, images and designs promoting a device, the label and packaging, websites and social media, articles and advertorials, posters and video. The TGA also publishes guidance on advertising personalised medical devices.
Review website copy, brochures and social media posts against the Advertising Code before launch, not after. Claims should match the intended purpose in your ARTG entry.
Common pitfalls
Relying on someone else’s ARTG entry. Each sponsor needs its own entry, even for an identical device.
Lodging too early. The TGA advises waiting until the Manufacturer Evidence is accepted before starting the inclusion application.
Missing Table 2 documents. An application without the prescribed documents is refused at preliminary assessment.
Using a non-Australian declaration. An EU declaration of conformity does not meet the Australian requirement.
Treating “exempt” as “unregulated”. Exempt dental devices still have to meet the Essential Principles, advertising and adverse event obligations.
Next steps
Getting a dental device onto the ARTG comes down to four things: knowing that the product is a device, getting the class right, holding evidence that suits that class, and lodging a complete application. The rules for personalised devices and UDI are still changing, so check the TGA’s current guidance before you apply.
If you are importing dental equipment or materials and are unsure about the class, the evidence or the documents your application needs, our medical devices team can review your file before you lodge.
Ready to talk about your dental device? Contact us for a quote.