Are You Meeting
TGA Regulatory Requirements?
Do you provide dental implant treatment?
Do you place implant components (implants or restorative)?
Do you know if you are meeting TGA Regulatory Requirements, or are you breaking the law?
Recently, a Dental Practice in Canberra was fined $266k for illegally importing dental implant components and bone grafting material. See more on this story here
Updates to Importing and Supplying Dental Implant Components:
This affects every Dental Professional that installs dental implant components (BOTH the dental implant and the restorative/abutment component).
In late 2020, the TGA updated their regulations for medical devices (including dental implants). The law now states that if you are installing a dental implant component, you are classed as a Supplier.
Suppliers have 2 main regulatory requirements:
Implant components you purchase/install MUST be registered on the Australian Register of Therapeutic Goods (ARTG)
Must provide a Patient Implant Card to your Patients.
Registered on ARTG:
While you may not be the manufacturer of the dental implant component, you are still responsible that the component is manufactured in line with TGA regulations. This can be achieved in a number of ways:
Purchase component from a TGA approved manufacturer (e.g. Southern Implants, BioHorizons, Nobel Biocare)
Confirm with your Manufacturer or Laboratory that the component has been registered on the ARTG (proof required)
Alternatively, if you are importing components made from overseas, you take on the responsibility of the supplier within Australia. For example, you purchase a component from Ebay/Alibaba - YOU must register this component with the ARTG (at a cost of $20,000)
Patient Implant Card
All implantable medical devices are required to have a Patient Implant Card that is provided to the Patient post-installation. Dental implants are no different.
Dental Manufacturers and Laboratories are required to provide an Implant Card with the device they are selling, and then it is the RESPONSIBILITY of the Dental Professional to add the Patients details to this card, and physically provide this card to the patient (post-installation).
If you are not providing a Patient Implant Card to your Patients, you are breaking the law.
Re-classification of Devices
There are different classifications for dental implant components, including 1. Custom-Made Medical Devices (CMMD), 2. Personalised Medical Devices (PMD), 3. Medical Device Production System (MDPS) and Adaptable Medical Devices (AMD).
You can read more about the re-classifications here <insert link here>, but as a summary:
Dental Implants used to be classed as Custom-Made Medical Devices. This meant they were able to pass through regulations as a like-for-like. Now, MOST dental implants are being classed as Personalised Medical Devices, as most of the restorative components are personalised for individual Patients.
This means, all dental implant components need to be registered on the ARTG. If they aren't and they are installed in Patients, the treating Dental Professional can be (and will be) charged accordingly.
How Can You Make Sure You Are Meeting Your Regulatory Requirements?
The Dental Implant Registry (DIR) is your one stop solution for all of your regulatory requirements.
The DIR allows Dental Professionals to register all of their Patients implant components on the DIR, which creates a digital Patient Implant Card.
This Digital Implant Card accessible by both your Practice and your Patients
This record also helps you meet the updated AHPRA Regulatory requirements of keeping patient records for 15 years
The DIR is able to help provide post-market surveillance on the devices you have used (another regulatory requirement of the TGA)
By recording this on the DIR, you are providing transparency to your Patients on the components you have installed
Do we add a link to more DIR Benefits landing page here?
Please contact the DIR team below if you have any questions, or click the "Register Today" button to Register your Practice on the DIR.