Understanding requirements for dental practitioners when making and adapting personalised medical devices
Guidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.
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Purpose
As a registered dental practitioner, you have responsibilities to act in accordance with the Dental Board of Australia's standards, codes, and guidelines.
You must be aware of and comply with other laws and regulations, including medical device regulatory responsibilities when importing dental devices (a sponsor), or manufacturing dental devices away from chair-side (a manufacturer and a sponsor).
Note
Sponsor means a person who:
exports the goods from Australia, or arranges for them to be exported;
imports the goods into Australia, or arranges for them to be imported; or
manufactures the goods in Australia, or arranges for them to be manufactured, for supply (either in Australia or overseas).
Sponsors have regulatory responsibilities for the devices they are importing and supplying. There are significant civil penalties for illegal import or supply of dental devices.
Unless exempt, all medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in Australia.
ARTG inclusion is required for:
- Mass-produced dental devices
- Adaptable medical devices that are manufactured in a way that allows them to be personalised to fit a patient after they are supplied
- Materials and components, specified to be a medical device, and intended to be used to make a non-implantable dental device for use in your practice
For more information about specified articles used in manufacturing patient-matched medical devices see Understanding specified articles and excluded products in personalised medical devices regulation.
There is no need to include your dental device in the ARTG if you buy:
Finished devices from a sponsor who has included them in the ARTG
When you buy finished devices from a sponsor who has already included them in the ARTG, you are NOT the sponsor, and you do not need to apply to include the dental devices in the ARTG.
This applies to mass-produced and adaptable medical devices.
Finished exempt devices from a sponsor
When you buy finished devices from a sponsor and the devices are exempt, you are NOT the sponsor, and you do not need to apply to include the dental devices in the ARTG.
This applies to devices covered by the transitional PMMD exemption pathway (until 1 July 2029) and the specified articles exemption pathway.
Materials and components to manufacture non-implantable dental medical devices from a sponsor who has included them in the ARTG
When you manufacture certain low-risk dental devices using only ARTG included materials and components, you will be the sponsor of the finished device, but the device will be exempt from ARTG inclusion under the specified articles exemption pathway.
There is no need to include your dental device in the ARTG if you manufacture:
Patient-matched medical devices (PMMDs)
When you manufacture patient-matched dental devices, you will be the sponsor of the finished device, but the device will be exempt from ARTG inclusion under the transitional PMMD exemption pathway until 1 July 2029. After this date, these devices must be included the in the ARTG before supplying them.
If you manufacture 5 or fewer PMMDs of a ‘kind of device’ in a financial year, these devices are exempt from ARTG inclusion under the low-volume exemption pathway.
You will still need to meet all other TGA regulatory obligations for medical devices.
This includes meeting the Essential Principles and ensuring you meet all advertising requirements.
Examples of regulation for dental devices
Patient-matched medical devices
Occlusal splints
Tashina is an Ahpra-registered dental practitioner.
Tashina sends casts of her patient’s teeth to an Australian-based dental laboratory so they can make personalised occlusal splints.
In this situation, the dental laboratory is the manufacturer because they make the splints. The dental laboratory is also the sponsor because they manufacture the splints in Australia. They must meet regulatory requirements before the splints can be supplied. Tashina is not the sponsor of the devices and does not need to include the devices in the ARTG.
- If the dental laboratory makes the occlusal splints using ARTG-included materials and under the direction of Tashina (a registered dental practitioner), the occlusal splints are exempt from ARTG inclusion.
- If the laboratory uses materials not included in the ARTG, the splints are temporarily exempt from ARTG inclusion until 1 July 2029. After this date, the occlusal splints must be included in the ARTG by the dental laboratory before supplying them.
In another situation, Tashina sends casts of her patient’s teeth to an overseas dental laboratory.
In this case, the overseas dental laboratory is the manufacturer because they make the splints. Tashina will be the sponsor of the finished device because she imports the personalised occlusal splints into Australia.
The occlusal splints themselves are exempt under the transitional PMMD exemption pathway (until 1 July 2029). Exempt devices must still meet relevant regulatory requirements.
Crowns
Amir is an Ahpra-registered dental practitioner.
Amir makes crowns using millable blocks or discs for his patients. He buys millable blocks from an Australian-based dental supplier to use as a raw material for making crowns. In this situation, the dental supplier is the sponsor of the millable blocks and must include them in the ARTG.
Amir is the manufacturer of the finished crowns because he makes them. He is also the sponsor of the finished crowns, because he manufactures these in Australia. Because he uses millable blocks that are already included in the ARTG, the crowns made by Amir are exempt. This means Amir does not have to include his crowns in the ARTG.
However, Amir will still need to meet all other regulatory obligations, including:
- meeting the Essential Principles
- complying with advertising requirements
If Amir imports millable blocks directly from overseas, he will be the sponsor of the millable blocks. Amir must include the millable blocks in the ARTG before he imports them.
The crowns Amir makes using the imported millable blocks that are included in the ARTG are exempt from ARTG inclusion and he will still need to meet all other regulatory obligations.
Note: Millable blocks or discs for crowns are not an adaptable device. They are a starting material specified to be a medical device.
Adaptable dental devices
Brackets and wires
Brackets and wires meet the definition of an adaptable medical device. These products require ARTG inclusion before they are imported or supplied to dentists. Subsequent assembly or adaptation for an individual patient is not an activity regulated by the TGA.
John is an Ahpra registered dentist.
He buys brackets and wires to make braces for his patients from a supplier (sponsor) who has included them in the ARTG. He uses these brackets and wires to assemble braces as part of his clinical practice.
In this scenario, John is not the sponsor of a medical device, and the braces he assembles do not need ARTG inclusion.
If John instead imports brackets and wires, he will be the sponsor of those devices. John must include the brackets and wires in the ARTG before he imports them.
Implantable dental devices
Implantable dental devices need to be included in the ARTG before they are imported into or supplied within Australia. Materials used to manufacture implantable dental devices are not included within the scope of the specified articles exemption pathway.
However, under the current transitional arrangements, PMMDs, including when implantable, are exempt from ARTG inclusion until 1 July 2029.
Examples of implantable dental devices include, but are not limited to:
- dental implants and implant abutments
- implant abutments with special attachments
- temporary anchorage devices (TADS), such as mini-screws
Dental devices that can be attached to implant abutments or fixed to TADS are exempt from ARTG inclusion when made using ARTG-included materials. Examples include crowns, bridges and fixed or removable non-implantable orthodontic appliances.
Page history
Updates to the PMD requirements and the examples
Original publication.
Updates to the PMD requirements and the examples
Original publication.