Hello Anon
The definition of exempt types of screw lists blocking screws, cap screws, and set screws, which don't sound applicable. However, see page 24, which specifically mentions endosseous implants as exempt.
And of course you may consider the note:
While these devices are exempted from the statutory requirement to provide patient information materials, the TGA strongly encourages manufacturers and sponsors to provide compliant patient information materials for these devices as a matter of best practice. Doing so will mean that patients and health practitioners using these devices will benefit from information about the devices in the same way as patients and health practitioners do for non-exempted implantable devices.------------------------------
Anne LeBlanc
United States
------------------------------
Original Message:
Sent: 12-Jan-2023 11:16
From: Anonymous Member
Subject: Australia Patient Implant card Patient information Leaflet
This message was posted by a user wishing to remain anonymous
Dear all,
I am seeking for clarification on the latest guidance from TGA : Medical Device Patient-information-leaflets-and-implant-cards v1.9.
Specially on the exempt product from this requirement.
Indeed, TGA recently updates the guidance and made the exemption product list more general.
Therefore I would like to know if dental implants remain exempt from the requirement or not as it was mentioned in previous guidance versions? Does this kind of product will fall under the definition of a screw as definred in the latest guidance from TGA ?
https://www.tga.gov.au/sites/default/files/medical-device-patient-information-leaflets-and-implant-cards.pdf
Many thanks in advance