Update from Eithne Irving, ADA Deputy CEO & General Manager of Policy

Custom-made medical devices - The current situation

Currently, custom-made medical devices are exempt from the requirement to be included in the Australia Register of Therapeutic Goods (ARTG). 

Custom-made medical devices are defined in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) as medical devices that are:
  •  
  • • Made specifically in accordance with a request by a health professional specifying its design characteristics or construction.
  • • Intended to be used only in relation to a particular individual, or by a health professional to meet special needs arising in the course of his or her practice.

Custom-made medical devices do not include off-the-shelf medical devices that have been adapted or modified to accommodate an individual patient.

Although custom-made medical devices are exempt from inclusion in the ARTG, they must still meet certain regulatory requirements.

The regulatory obligations of manufacturers of custom-made medical devices are outlined in Part 7, Schedule 3 of the Regulations. In brief, manufacturers and sponsors of custom-made medical devices must:
  •  
  • • Ensure their devices conform to the Essential principles 
  • • Maintain specific records pertaining to each of the devices they manufacture; and
  • • Must notify the TGA of any adverse events involving these devices.

In summary, dentists who are making custom-made medical devices in their practice such as mouthguards, dentures, splints etc are currently required to notify the TGA that they manufacture such devices. If you have never reported these devices before and wish to continue to provide these in your practice you must notify the TGA before the 25th February to access transitional arrangements under the new legislative framework.

Additionally, if you are outsourcing laboratory work overseas, you will deemed to be a sponsor under the regulations, and also have reporting requirements.

 

Importing medical devices – The current situation

All medical devices imported into, or supplied within, Australia must also be included in the ARTG by an Australian-based legal entity known as the sponsor. If you source your devices from an Australian sponsor who has included the device in the ARTG, you do not need to include the device in the ARTG yourself. If your device has not been included in the ARTG by an Australian based sponsor, it is likely that you will be responsible for including the devices in the ARTG. There is a three-step process for registering a device which we have outlined below.

Essentially, each “kind of device” will ultimately need separate TGA listing and approval. The duty to apply for TGA approval, payment of fees, and submission of relevant paperwork to the TGA each year rests with the sponsor of the device (in most cases the manufacturer will also be the sponsor). Overseas manufacturers must always assign the responsibilities of a sponsor to an Australian legal entity.

An inclusion in the ARTG is for a “kind of device”. This means that providing your devices have particular characteristics in common, you will only have one inclusion in the ARTG. You can read the definition of “kind of device” at https://www.tga.gov.au/kind-medical-device.  

In summary if you import a medical device (s) from overseas, you are the sponsor of that device and should have TGA approval. If you have never registered these products you must notify the TGA before the 25th February to access transitional arrangements under the new legislative framework. 

 

What is changing?

On 25th February 2021 a new legislative framework for custom-made medical devices will be introduced and what dentists manufacture and/or supply to patients may no longer be exempt from the requirement to be included in the Australia Register of Therapeutic Goods (ARTG). Most of currently supplied custom-made medical devices will now meet the definition of a patient-matched medical device.

The new definition of a patient matched medical device means a medical device that:
  •  
  •       (a) is manufactured by the manufacturer, within a specified design envelope, to match:
  1.          (i) either or both of the anatomical and physiological features of a particular individual; or
  2.          (ii) a pathological condition of a particular individual; and
  3. (b) is designed by the manufacturer (even if the design is developed in consultation with a health professional); and
  4. (c) is manufactured using production processes that are capable of being:
  5.          (i) either or both validated and verified; and reproduced
 

What do I need to do if I manufacture or sponsor patient-matched devices?

First, identify if any of the devices you are currently using are affected by the change. You will then need to determine who is responsible for fulfilling the regulatory requirements for these devices.   

The TGA is not concerned with the material used to form a custom-made medical devices just the end product. Examples of custom-made medical devices include but is not limited to: 

  •        Veneers, Crown and bridge, Mouthguards, Splints, Retainers, Mandibular advancement splints, custom
  •        made trays, Dentures – all types including implant retained overdentures, surgical guides 

While the new regulatory framework comes into effect very soon (25 February 2021), there are transition arrangements in place to ensure you can continue to supply devices while you apply for them to be included in the ARTG. These transitional arrangements only apply if you notify the TGA of your custom-made medical device(s) by the 25th February 2021. 

Please note, if you employ a dental technician who manufacturers devices on your prescription, you are deemed to be the manufacturer and responsible for notifying the TGA. However, if you subcontract the laboratory work, the responsibility lies with the contractor/laboratory. 

If you are responsible:
 
  1. 1. before 25 February 2021: submit a custom-made medical device notification to the TGA. As mentioned earlier, submitting notification of the manufacture and/or supply of a custom-made medical device is an existing regulatory requirement. If you are unsure if you have previously notified the TGA it's best to err on the side of caution and submit the form again, ensuring you have met your regulatory obligations and also that the TGA has your current contact information. You will need to submit this form for each kind of device that you either produce or import. You will need to know the classification of each device submitted - see THIS section of the TGA website to work out your device/s classification. If the name of your business or your contact details change, you should re-submit this form as this is the primary method of communication the TGA will use to contact you. 
  2.  
  3. 2. before 25 August 2021: submit a notification to access transition arrangements to the TGA. Completing a transition notification will allow you to continue supplying your device as you transition to an ARTG inclusion. If you register for transition and later find that you don't need to proceed with including the device, then the notification form will simply become redundant. You will not be compelled to include a device that is registered for transition if you later choose not to proceed with listing it in the ARTG.
     
  4. 3. before 1 November 2024: ensure you have appropriate evidence of conformity assessment and submit an application for inclusion in the ARTG. However, you must complete the above two steps to allow continued supply of your devices while you transition your device for inclusion in the ARTG.
  5.  

TGA Decision Tree

To make it easier to understand these steps we have developed a decision tree.

  1.  

When don’t I need to do anything?

You are NOT required to take action with the TGA if:
 
  • • a device you use is manufactured by an Australian company/laboratory, and they have taken responsibility for the TGA approval and ARTG listing.
  • • a device you use is manufactured by an overseas laboratory/company and this company has a presence within Australia e.g. commercial aligners (such as Invisalign), the devices will most likely already have TGA approval via the product importer - you can check this on the ARTG.
  • • a device you use is manufactured within your practice using a Medical device production system (MDPS) and in accordance with the manufacturer’s instructions, and that system is already listed in the ARTG (e.g. cerec unit), then you will not need to include the devices you produce with that system in the ARTG.

Once you notify the TGA of your custom-made medical device (s) you will be able to continue to provide these products while transitional processes are in place.

If you do not notify or report your custom-made medical device (s) by the 25th February you will no longer be able to provide these devices until you register them under the ARTG which will incur fees and require you to provide a conformity assessment, market authorisation, post-market monitoring and compliance related documents.