Personalised Dental Device Guidance Updated

Personalised Dental Device Guidance Updated

The TGA updated its guidance for dental practitioners on 1 July 2026.

Personalised medical devices can include dentures, aligners, retainers, splints, crowns, bridges and patient-specific appliances. Regulatory responsibilities may vary depending on whether the practice manufactures, imports, supplies or adapts the device.

Practices should review:

• who manufactures and supplies each device;

• whether devices and materials are appropriately included in the ARTG;

• laboratory and supplier documentation;

• device identification and patient records; and

• whether the practice has additional obligations when importing or manufacturing devices away from the chairside.

Patient-matched devices remain temporarily exempt from ARTG inclusion until 1 July 2029, but other regulatory and record-keeping requirements may still apply.

References

• TGA — Understanding Requirements for Dental Practitioners When Making and Adapting Personalised Medical Devices

• TGA — Personalised Medical Devices

Disclaimer: This information is provided for general educational purposes only and does not constitute clinical, regulatory or legal advice. Dental practices and practitioners should review the full current guidance and seek professional advice where their responsibilities are unclear.