The Australian and New Zealand Dental Implant Registry: Regulatory Requirements and Registry Development

The Therapeutic Goods Administration is responsible for the Regulation of manufacture and supply of all medical devices including dental implants. Medically, the patient is given a 'Patient Implant Card' (PIC). It is recommended to monitor the performance of devices in an implant registry.

The TGA Regulations were reviewed. The detailed methodology to establish a National Dental Implant Registry is presented and initial analysis performed.

The placement of dental implants in Australia is not as regulated as other comparable medical devices. Currently the Registry has 43 clinics with 44 participating dental practitioners. The DIR has recorded dental implant related information from 4842 patients with 9429 devices (Australian and New Zealand data). Patients were usually over 60 years of age, more female and more implants were placed in the maxilla. The Australian replacement rate of dental implants was 1.83% and 1.42% for prostheses.

Improving the regulatory framework by introducing the issuing of Patient implant cards (PICs) so the specific device information type is transferable and retained long term and establishment of long-term independent monitoring in a Dental Implant Registry, crucial in identifying problems with the aim of improving outcomes for patients and dental professionals should be considered.