Refinements to the Personalised Medical Device Framework

A public consultation was held on personalised medical devices in July 2021.

Refinements include:

1. Exclusion of specified products
2. Declaration of some products to be medical devices.

Excluded products

Public consultation showed how important the TGA is as a regulator. In most cases, medical devices shouldn't be excluded from regulation, even if they pose a low risk.

Products proposed for exclusion are limited to the following:

• Those already excluded or that don't qualify as medical devices, but whose regulatory status needs clarifying.
• Accessories for medical devices whose regulation under the framework doesn't suit the risk they pose.
• Cosmetic products that meet the definition of medical devices.
• Models made from a cast taken directly from the anatomy of a patient. 

The Therapeutic Goods (Excluded Goods) Determination 2018 excludes these products:

• Anatomical models intended to be used for educational or record-keeping purposes.
• Cosmetic finishing components for orthoses and prostheses.
• Craniofacial prostheses that are
  • spectacle-retained
  • adhesive-retained.
• Dental impression trays.
• Ear moulds that are intended by the manufacturer to anchor hearing aids.
• Medicament trays that are intended by the manufacturer to hold medicaments.
• Mouthguards that protect teeth from external forces, including contact sports mouthguards.
• Ocular prostheses intended by the manufacturer to be used for cosmetic purposes.
• Physical impressions of anatomy, and models cast from such impressions.
• Spectacle frames.

Impact

The exclusion means that the specified products are not subject to regulation by the TGA. For example, if they're advertised or supplied for a specific purpose.

Excluded products don't have to meet any Australian regulatory requirements for medical devices.

This means they are not required to be assessed in any way by the TGA before they are supplied. They are not able to be included in the Australian Register of Therapeutic Goods (ARTG).

Suppliers of excluded products are not required to report adverse events to the TGA.

These products will still be subject to other regulatory requirements. These include the Australian Competition and Consumer Commission (ACCC) consumer protection laws and state or territory consumer protection laws.

If you make or supply a product that is excluded, you don't need to include it in the ARTG.

No action is required if you have already included a product in the ARTG that is mentioned in the Therapeutic Goods (Excluded Goods) Determination 2018. 

Specified articles

Feedback received from the consultation indicated:

• Making medical devices is a key component of clinical practice in many sectors.
• Risks associated with devices manufactured by healthcare practitioners or technicians/laboratories working to their instruction/direction are managed in a profoundly different way to mass-produced devices.
• Without the benefit of the custom-made medical device exemption and/or the inclusion of the starting materials/components used in these devices in the ARTG, it will be difficult, if not impossible, for some healthcare practitioners to continue supplying medical devices.

Including starting materials and components used to make these devices in the ARTG, is a well-established practice that:

• Aligns with other jurisdictions. The EU regulates some medical devices as part of clinical practice.
• Manages the risks associated with the device at two key stages when the:
  • material/component is formed and
  • materials/components are used to make a device.
• Treats the device's final assembly by a healthcare practitioner (or a laboratory/technician working to instructions from a healthcare practitioner) as a part of clinical practice. As such, it is regulated by the Ahpra and other professional bodies.

To manage device risks effectively without burdening healthcare practitioners or the technicians and laboratories that service them, an alternative pathway is needed for devices made under these circumstances.

The Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 declares certain products, including starting materials and components used in the manufacture of some medical devices to be a medical device.

This instrument covers two main groups of products/devices:

1. Medical devices that already meet the definition, but where clarification of regulatory status would be useful to healthcare practitioners and industry.
2. Starting materials or components used by a healthcare professional in the manufacture of a medical device, or according to their directions.

The instrument specifies the following products, predominately used in the dental and allied health sectors, to be medical devices:

• Materials for direct tooth restoration, including but not limited to:
  • amalgam;
  • composite resins and respective bonding systems;
  • core build-up materials;
  • crown forms;
  • fibre or metal preformed posts;
  • fibre reinforcement materials;
  • fissure sealants;
  • glass ionomers;
  • liners and bases;
  • resin-modified glass ionomers; and
  • temporary crown or bridge materials.
• Materials and articles that a dentist can use for indirect restorations, like:
  • ceramic;
  • crown forms;
  • metal alloy; and
  • temporary crown or bridge materials.
• Materials and other articles to be supplied or used by a relevant practitioner in the manufacture of externally-applied orthopaedic devices. Including but not limited to:
  • fibreglass bandages used in the manufacture of splints or orthoses;
  • software; and
  • thermoplastic sheeting used in the manufacture of splints or orthoses.
• Materials and other articles to be supplied or used by a relevant practitioner to manufacture non-implantable dental appliances. Including but not limited to:
  • acrylic;
  • denture repair or reline materials;
  • metal alloy used in casting;
  • orthodontic components. Such as bands, brackets, chains, elastics, ligature ties, separators, and wire;
  • palate expanders;
  • preformed acrylic teeth;
  • preformed clasps;
  • software;
  • thermoplastic; and
  • wrought wire used in the manufacture of clasps or retainers.
• materials and other articles used by a relevant practitioner to obtain dental impressions.

Impact

For devices supplied to dental professionals, such as amalgam, there is no change in regulation.

These products remain an adaptable medical device. Before they are supplied to a practitioner, they must be included in the ARTG. Practitioners who use them have no regulatory obligations with the TGA.

For all other devices named in the instrument, where a device is:

• Produced at the direction, or according to the instructions of a healthcare professional
• Using a material or component named in the instrument that is included in the ARTG

the finished device will not need to be included in the ARTG.

The person assembling the device will still need to meet all other regulations for medical devices, including:

• Making sure device(s) meet all relevant Essential Principles. This includes supplying the devices with adequate labelling and instructions for use;
• Meeting advertising requirements for therapeutic goods.

If you are a:

• A healthcare practitioner who manufactures a specific device as part of your clinical practice; or
• An entity that manufactures specific devices for healthcare practitioners,

you will not be required to include your devices in the ARTG if you are making them exclusively from an ARTG-included material or component(s).

Patient-matched medical devices (PMMDs)

The transition notification period for patient-matched medical devices (PMMDs) ended 1 November 2024.

All PMMDs will remain exempt from ARTG inclusion until 1 July 2029. Until then they can be manufactured and/or supplied, regardless of whether a notification was made prior to 1 November 2024.

After 1 July 2029, all PMMDs (including notified PMMDs) must be included in the ARTG. You will need this before you import, supply, or export them, unless they are exempt, excluded or otherwise approved by us.

Exempt devices are exempt from inclusion in the ARTG. They are not exempt from regulation. Exempt medical device manufacturers and sponsors still have to comply with TGA regulations. These include meeting the Essential Principles and advertising requirements.

Starting material, component(s) used to manufacture a medical device for a particular purpose, and finished medical devices directly imported into Australia, must be included in the ARTG. They cannot be supplied otherwise.

Next steps

The instrument is mostly for starting materials and components used in the dental and allied health sectors. However, Ahpra and peak professional bodies say it could be used for other sectors as well.

We are currently conducting work to engage with stakeholders in these sectors. We engage both directly and through peak professional and industry bodies, to identify more products that could be better regulated this way.

See Point-of-care manufacturing of medical devices for more information.