IMPORTANT UPDATE: 23 August 2021 - The regulation of patient matched devices has been separated into materials and components so unless you importing materials, components, devices or manufacturing devices with materials not already on the ARTG, you do not have to register directly with the TGA. The responsibility for this will lie with the suppliers of the materials and the components.
19 February 2021 – An announcement has been made by the ADA that the compliance date has been moved from 25 February 2021 to 25 August 2021. This means that dentists will now have until 25 August 2021 to notify and apply for transitional arrangements. We will continue to update our advice as the matter unfolds. If you do not notify the TGA of your devices before 25 August 2021, you must cease supplying them from 25 August 2021 and not resume supply until you have an inclusion in the ARTG.
The Therapeutic Goods Administration (TGA) has amended regulations for custom-made medical devices. The changes came into effect from 25 February 2021 and will mainly effect dental labs and clinicians who manufacture, import or export personalised dental devices for patients.
Under regulation that was in effect before 25 February 2021, custom-made medical devices were not required to be included in the Australian Register of Therapeutic Goods (ARTG). The TGA recognizes that custom-made medical devices (including orthopedic implants) are constantly changing and may carry with them a higher risk. In order to provide further oversight, the TGA has designed a new framework for medical devices that are designed and manufactured for individual patients – the personalised medical devices framework.
What are the new changes?
1) Many devices will now need to be included in the ARTG
2) Annual reporting of the custom-made medical devices supplied in the past financial year is required.
3) The TGA may inspect the production facilities
4) Documentation about the device is to be kept for 5 years (for non-implantable devices, such as dentures) and 15 years (for implantable devices)
5) The manufacturer (the person responsible for the design, production, packaging and labelling of the device) is to provide information about each custom-made medical device to the intended recipient. The information must include the name and address of the manufacturer, information identifying the device, a statement to say that the device is only for the sole purpose of the named individual, the name and address of the health professional who provided the specifications for the device.
Further information must also be provided so that the individual (and their healthcare provider) can make informed decisions about to allow the device to continue to perform as intended, maintain the device and manage risks associated with its use.
The first thing to be done will be to determine whether the device you provide falls within one of the four categories and whether you are a manufacturer or a sponsor of the device:
1) Patient-matched medical device – devices that are manufactured and designed by the manufacturer, to match anatomical and/or physiological features of an individual using a process that can be validated and/or verified and reproduced. An example would be the manufacture of a dental retainer. Such devices will need to be included in the ARTG before they are supplied.
2) Devices produced using a Medical Device Production System - a system consisting of raw materials and production equipment that a healthcare professional or facility can use to manufacture a personalised medical device. An example would be crowns made using an in-house milling machine.
If you are a health professional currently using a system to produce patient-matched medical devices, you currently meet the definition of a manufacturer under section 41BG of the Act and will need to ensure you are meeting your regulatory obligations by registering for transition.
Once the MDPS facilty is available (currently there is no date for this), dentists will be able to supply devices you use an MDPS that has been included in the ARTG and you only use the MDPS to produce devices in accordance with the intended purpose and instructions for use. If materials other than those supplied by the MDPS manufacturer are used, the dentist will meet the definition of manufacturer.
3) Custom-made medical device – exempt from inclusion to the ARTG but the manufacturer/sponsor still has obligations with regards to the information that needs to be supplied, record keeping requirements, annual reporting and allowing inspection and review
4) Adaptable medical device – a mass produced device that is assembled or adapted in accordance with the manufacturer’s instructions
Each “kind” of device will need to be registered, regardless of how many are produced.
What is a personalised medical device?
A medical device designed and manufactured in such a way that it matches anatomical and/or physiological features of a particular individual or is used to treat a pathological condition for a particular individual. The process in the manufacture of the device should be reproducible, with production process that can be validated and verified. For dentistry, this would include bridges, dentures and crowns or custom-made orthodontic aligners or retainers. Most personalised devices will need to be included in the ARTG.
What if I create crowns using a milling machine?
A milling machine would be defined to be a Medical Device Production System (MDPS) – a system consisting of raw materials and production equipment that a healthcare professional or facility can use to manufacture a personalised medical device.
While the definition of an MDPS will enter the Regulations from 25 February this year, the definition will not take effect in law until the TGA takes steps to declare an MDPS to be a medical device.
It will also not be mandatory for production systems to be included in the ARTG as MDPSs. A production system will only be an MDPS if the manufacturer of the system (1) intends for it to be an MDPS and (2) obtains approval from the TGA includes it in the ARTG as an MDPS.
It is the manufacturer of this system and not the user that is deemed to be the manufacturer of any devices produced using the system, as long as the system is used in accordance with the manufacturer’s instructions.
If the milling machine was included in the ARTG as an MDPS, the users would need to strictly adhere to the instructions for use provided by the manufacturer, including any requirements for materials.
If a clinician were to operate the MPDS outside of the instructions for use- including by substituting brands of materials- they would not be operating the MDPS in accordance with the legislation and would need to include their devices in the ARTG before they were supplied.
If a clinician uses the system outside of the instructions of use, for example using different raw materials, or allowing a staff member who is not a health professional to use the system, they will be deemed to be a manufacturer and will be required to comply with all the relevant requirements.
If a milling machine is used before an MDPS is declared to be a medical device, the user of the machine will be deemed to be the manufacturer. Currently, as MDP systems are not included in the Regulations, all dentists milling a crown will be deemed to be a manufacturer/sponsor.
What about the scanners I use to scan teeth?
From 25 February, a scanner will be deemed to be a Class IIa device and will need to be included in the ARTG. However, the responsibility of this lies with the manufacturer of the device and not the end user.
If you are directly importing the scanners from overseas, you may be deemed to be a sponsor of the device and may need to include the device in the ARTG.
What if I use a laboratory overseas?
If a clinician sources their dental devices from abroad, that clinician may be deemed to be the sponsor (this is the Australian entity responsible for ensuring all the related requirements are met). You will therefore have to:
- Ensure that the manufacturer abroad has evidence of appropriate conformity assessment for the devices
- Include the devices in the ARTG
- Meet all the relevant ongoing responsibilities.
I use a company that has an office in Australia but sends the work to be completed abroad. Do I need to be the sponsor for the devices?
You will need to contact the business based in Australia to find out whether they sponsor the devices that you intend to use. You can check whether the device you intend to use is on the ARTG by checking on the TGA website.
I make suckdown splints in my surgery for mouthguards and/or whitening trays. What do this mean for me?
Devices that are mouthguards or teeth whitening trays and are used only as non-sterile protective equipment or in teeth whitening are excluded under the Therapeutic Goods (Excluded Goods) Determination 2018.
If you use these devices for use other than whitening or protective mouthguards, you very likely would be deemed to be the manufacturer of a personalised medical device and therefore would need to include the devices you make in the ARTG.
I currently supply devices. What’s my timeline for the changes?
If you are the manufacturer or sponsor of devices before 25 February 2021, transition arrangements are in place to allow you to continue to supply the devices. You must show that you were supplying the device before prior to 25 February 2021 (for example by notifying the TGA.)
25 February 2021 – changes come into place
Before 25 August 2021 – complete the online transition form to access transition arrangements
Before 1 November 2024 – submit an application for inclusion in the ARTG. This may require you to provide information to demonstrate that the medical device complies with the regulatory requirements in Australia, and provide documentation/information relating to the regulatory, technical, clinical and safety aspects of the device.
If you do not notify the TGA of your devices before 25 August 2021, you must cease supplying them from 25 August 2021 and not resume supply until you have an inclusion in the ARTG.
If you notify the TGA before 25 August 2021 that you have a custom-made medical device that must transition to a patient-matched medical device, you will need to submit an application for inclusion before 1 November 2024.
If you then do not submit your application by 1 November 2024, you must cease supply on or before this date.
Where can I find out more information?
The information provided gives a basic overview of the new changes and regulations that will come into place from 25 February, however we recognise that individual practitioners and businesses will have different specifications and that we cannot account for all these variations. The TGA has published a FAQ section recently and this can be found on: https://www.tga.gov.au/regulatory-framework-personalised-medical-devices-frequently-asked-questions
Further to this, the TGA can be contacted at [email protected] with any specific questions related to your personal situations. Further information about including devices on the ARTG can also be found at the Therapeutic Goods Administration website.
The online classification tool – can be used to confirm the classification of devices