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 Board's standards, codes, and guidelines.
You must be aware of and comply with other laws and regulations, including regulatory responsibilities to the TGA when importing dental devices (a sponsor), or manufacturing dental devices away from chair-side (a manufacturer and a sponsor).
ARTG inclusion is required for:
- Finished or unfinished dental devices imported from overseas
- Materials and/or components intended to be used to make a dental device for use in your practice
- Dental devices made from materials and/or components bought from an Australian-based supplier who has not included the materials and/or components in the ARTG
- Implantable dental devices even when manufactured using materials and/or components bought from an Australian-based supplier who has included the materials and/or components on the ARTG.
If you are undertaking any of these activities, it is likely you are the sponsor of the device. Sponsors have regulatory responsibilities, including the need to include your devices in the ARTG.
Note: Sponsors must be an Australian-based legal entity who has their own ARTG inclusion for the devices they are importing and supplying. There are significant civil penalties for illegal import and/or supply of dental devices.
There is no need to include your dental device in the ARTG if you buy:
- Finished devices from an Australian-based sponsor who has included them in the ARTG
When you buy finished devices from an Australian 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.
- Materials and components to manufacture non-implantable dental medical devices from an Australian-based sponsor who has included them in the ARTG
When you manufacture 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. You will still need to meet all other TGA regulatory obligations for medical devices.
This includes meeting the Essential Principles, reporting adverse events 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. If the dental laboratory makes the occlusal splints using ARTG-included materials, the occlusal splints are exempt from ARTG inclusion.
However, the dental laboratory is the sponsor if they make the occlusal splints using materials not included in the ARTG. The occlusal splints must be included the in the ARTG by the dental laboratory.
Tashina is not the sponsor of the devices and does not need to register the devices in the ARTG.
However, if Tashina decides to send casts of her patient’s teeth to an overseas dental laboratory to make personalised occlusal splints and import the splints into Australia, she will be the sponsor and will need to include the devices in the ARTG before she imports them.
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 (sponsor) who has included the millable blocks in the ARTG. Amir is the sponsor of the finished crowns he manufactures from the millable blocks. Because the materials he used are 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:
- supplying instructions for use
- meeting the Essential Principles
- reporting all adverse events
- Complying with advertising requirements
If Amir decides to import millable blocks direct from overseas, he will be the sponsor of the millable blocks and the crowns he makes with them. Amir must include the millable blocks in the ARTG before he imports them.
The crowns Amir makes using the imported millable blocks that he has included in the ARTG are exempt from ARTG inclusion and he will still need to meet all other regulatory obligations, including:
- supplying instructions for use
- meeting the Essential Principles
- reporting all adverse events
- Complying with advertising requirements
Note: millable blocks or discs for crowns are not an adaptable device. Millable blocks or discs for crowns are a starting material specified to be a medical device.
3D printing of a surgical guide
Maya is an Ahpra registered dental practitioner.
Maya uses a 3D printer to make a wide range of dental devices. The 3D printer Maya uses is not a medical device. It is a piece of manufacturing equipment and does not need ARTG inclusion.
Maya 3D prints a dental surgical guide to aid implant placement on one of her patients. She buys the resin to make the surgical guide from an Australian-based supplier (sponsor), who has included the resin in the ARTG. The surgical guide Maya makes from ARTG included materials is exempt and does not need ARTG inclusion.
Maya would like to use a new resin intended for use in dental devices that can only be sourced from an overseas supplier. Maya imports the resin into Australia. Maya is the sponsor and is regulated by the TGA and the new resin will need to be included in the ARTG. The surgical guides Maya makes using the new resin that she has included in the ARTG, are exempt from ARTG inclusion. However, she will still need to meet all other regulatory obligations, including:
- supplying instructions for use
- meeting the Essential Principles
- reporting all adverse events
- complying with advertising requirements
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 an Australian-based supplier (sponsor) who has included them in the ARTG. The braces John assembles are a part of his clinical practice.
John is not the sponsor of a medical device and the braces do not need ARTG inclusion.
If John imports brackets and wires to assemble braces, John will be the sponsor. 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. Implantable dental devices are not exempt from ARTG inclusion when made using materials included in the ARTG. 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 miniscrews
Dental devices 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
Original publication.
Original publication.