TGA Updates Guidance for Dental Practitioners on Personalised Medical Devices
The Therapeutic Goods Administration (TGA) has updated its guidance “Understanding requirements for dental practitioners when making and adapting personalised medical devices”.
The guidance is intended for Ahpra-registered dental practitioners and explains regulatory requirements that may apply when dental practitioners make, import or adapt personalised medical devices for patients.
The document was originally published on 23 April 2024 and last updated on 1 July 2026, with updates to personalised medical device requirements and examples.
ARTG Inclusion and Exemptions
The TGA states that, unless exempt, all medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia.
ARTG inclusion is required for:
mass-produced dental devices;
adaptable medical devices manufactured to be personalised after supply;
materials and components specified as medical devices and intended to be used to make non-implantable dental devices for use in practice.
However, dental practitioners do not need to include a dental device in the ARTG where they buy finished devices from a sponsor who has already included them in the ARTG, or where they buy finished exempt devices from a sponsor.
Patient-Matched and Adaptable Dental Devices
The guidance explains that when a dental practitioner manufactures patient-matched medical devices, they may become the sponsor of the finished device. These devices may be exempt from ARTG inclusion under the transitional PMMD exemption pathway until 1 July 2029.
After this date, patient-matched medical devices must be included in the ARTG before they are supplied, unless another exemption applies.
The TGA also clarifies that where a practitioner manufactures five or fewer patient-matched medical devices of a kind of device in a financial year, these may be exempt under the low-volume exemption pathway.
For adaptable dental devices, such as brackets and wires, ARTG inclusion is required before they are imported or supplied to dentists. However, subsequent assembly or adaptation for an individual patient as part of clinical practice is not regulated by the TGA.
Implantable Dental Devices
The guidance states that implantable dental devices must be included in the ARTG before they are imported into, or supplied within, Australia.
Examples include:
dental implants and implant abutments;
implant abutments with special attachments;
temporary anchorage devices, such as mini-screws.
The TGA also notes that materials used to manufacture implantable dental devices are not covered by the specified articles exemption pathway. However, under current transitional arrangements, patient-matched medical devices, including implantable devices, are exempt from ARTG inclusion until 1 July 2029.
Impact on Medical Device Manufacturers and Dental Device Suppliers
For dental device manufacturers, sponsors and suppliers, the guidance reinforces the importance of clearly understanding who is acting as the manufacturer and who is acting as the sponsor under Australian medical device legislation.
Manufacturers and suppliers should pay particular attention to:
whether the device must be included in the ARTG;
whether an exemption pathway applies;
the supply of ARTG-included materials and components;
the regulatory status of patient-matched and adaptable devices;
obligations for implantable dental devices;
compliance with the Essential Principles and advertising requirements.
For dental practitioners importing devices or manufacturing devices away from chair-side, the guidance highlights that they may take on sponsor or manufacturer responsibilities and must ensure that applicable TGA regulatory obligations are met.
