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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.