ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

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TGA Implant Card Requirements And Dental Implants

TGA Implant Card Requirements And Dental Implants

23rd Oct 18

Summary —

The Therapeutic Goods Administration (TGA) has released guidance on the information that must be provided to patients with certain types of implantable medical devices, having regards for the fact that most dental implants, dental fillings and certain other dental products are excluded from the requirement.

Key Issues For The Dental Industry —

In late October 2018 the Australian Government approved regulations to require certain consumer information materials to be supplied with implantable and active implantable medical devices in Australia.

The patient implant card is a small, portable card intended to be provided to patients (after surgery) who have received either a permanent implantable medical device (except exempted devices as noted below), or an active implantable medical device.

The card must contain the name, type and model of the implant they have received. Importantly, the patient card must contain the manufacturer's contact details (including website details) that will enable patients to seek further information or updates on their implanted device.

The leaflet may also be used to provide patients with the name and manufacturer of the device and information about what may happen after the surgery including possible adverse events and malfunctions.  The TGA has suggested that the leaflet may also be used during discussions after surgery, for example to explain how to report adverse events and prompts to visit the doctor if the patient suspects malfunction of the device. Information about how to use or precautions (if any) to take may be included in the discussion.

A copy of the TGA's guidance on the type of information that suppliers of medical devices can be downloaded from the link below:

 

TGA Regulatory Guidance —

â–  Medical device patient cards and leaflets [PDF] *

The Australian Dental Industry Association (ADIA) was, with the support of its members, a strong and effective advocate to have certain types of dental products excluded from the list of products for which a supplier must provided a patient information card.  ADIA's policy advocacy was based upon research that demonstrated low-level of risk to patients associated with these products.  After prolonged negotiations, the TGA accepted ADIA’s advice and products excluded from the requirement to provide a patient information card include dental fillings, dental braces, tooth crowns and general (endosseous) dental implants are excluded from the requirements.  Dental implants received by patients during high risk major jaw surgery, such as subperiosteal, transosseous, zygomatic and transcutaneous implants are not excluded from the provision of the patient implant cards and patient information leaflet.

Where there is a requirement to provide a leaflet, suppliers of dental implants within Australia must ensure that consumers and healthcare professionals have ready access to the patient information leaflet. It is expected that unless it is impracticable or inappropriate to do so, the leaflet is provided with a medical device. The access to the leaflet should be free of charge.

Further Information —

The ADIA Policy Team negotiating with the Australian Government on matters concerning dental product regulation receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee.

Further Information —

To keep up to date with all matters associated with dental product regulation follow ADIA on Facebook at www.facebook.com/dental.industry or the Twitter feed @AusDental. For further information on ADIA's engagement with the TGA on fees and charges send an email to policy@adia.org.au or telephone 1300 943 093.

Currency & Disclaimer —

This update was issued on 23 October 2018 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here. 


This publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated. 

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