ZYGOMATIC IMPLANTS:
THE DIR CAN HELP YOU
MEET YOUR TGA REQUIREMENTS

From 1st December 2021, the TGA are requiring all patients receiving

zygomatic implants to have patient information materials available to them in the form of a Patient Implant Card (PIC) and Patient Information Leaflet (PIL)

TGA Regulations

Patient Implant Card (PIC)

The purpose of a PIC is to ensure patients are aware of the details of the device they have received, and that health professionals can also identify this device.

 

It is the Dental Professional's responsibility to supply the PIC to their Patient, and this can either be as a physical or digital card.

Did You Know?

The Dental Implant Registry (DIR) creates a digital PIC?

Registrations done via the DIR are fast, accurate and securely stored for the Patients lifetime. A DIR Registration not only meets all the TGA requirements, but also provides your Practice with a variety of additional benefits, including paying you or your practice for the data entry (takes approximately 1-2 minutes and can be entered by your staff).

DIR Registration.png

Patient Information Leaflet (PIL)

Separate from the implant card, the PIL is provided to surgeons from the manufacturer along with their zygomatic implant. The purpose of a PIL is to ensure that Dental Professionals and their Patients are aware of the medical device PRIOR to surgery, to assist Patient-Doctor discussions regarding:

  • The type of medical device being considered

  • The type of medical condition the device is used for

  • The name and manufacturer of the device

  • Information about what may happen after surgery

  • Information about possible adverse events or malfunctions

Register Your Practice on the DIR Today

Register your Practice on the DIR and find out how easy it is to meet your TGA regulatory requirements while also benefitting from all the DIR has to offer!

FAQs

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Please contact the DIR team below if you have any questions.

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