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Custom-made medical devices

Information for sponsors, health professionals & manufacturers

15 April 2021

The way that custom-made medical devices are regulated has changed

On 25 February 2021 a new framework for regulating personalised medical devices commenced. The framework includes a new definition for custom-made medical devices. The impact of the new definition is the majority of devices previously supplied under the exemption for custom-made medical devices no longer meet the definition of a custom-made medical device and will need to be included in the Australian Register of Therapeutic Goods (ARTG).

If you were supplying a custom-made medical device before 25 February 2021 that is now a patient matched medical device, transition arrangements are in place that will allow you to continue to supply devices until 1 November 2024. To access the transition period, you will need to register using the online form before 25 August 2021: NOTIFICATION FORM: Transition arrangements for custom-made medical devices

More information about the new framework, including information about the changes to how custom-made medical devices are regulated, frequently asked questions and resources to assist you with transition, is available on our website: Personalised medical devices (including 3D-printed devices)

You can also send an email to devices@health.gov.au with 'SUBSCRIBE PMD' in the subject line to receive:

  • notification when guidance documents and other information resources are published;
  • updates about the new framework;
  • reminders about the transition period; and
  • details about webinars and workshops.

Notifying the TGA of custom-made medical devices

Certain information about medical devices that meet the new definition of a custom-made medical device that commenced on 25 February 2021 must be provided to the TGA.

If you are:

  • the Australian manufacturer of a custom-made medical device; or
  • the Australian sponsor (supplier) of a custom-made medical device that was manufactured overseas;

Then you are required under regulation 10.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations), to notify the TGA of such.

Notification is required within two months of manufacture or initial supply of the custom-made medical device.

An online custom-made medical devices notification form is provided for your convenience to simplify the process. Please note that this form is not the form used to register a patient-matched medical device for transition.

Note

You will receive a copy of the notification form you submit to the TGA to the nominated email address. You will need to quote the reference number for the notification when you submit your annual report.

The nominated email address in this form will also be where the TGA will direct further communications with you. If the contact details for your business change, you should submit a new notification form to the TGA.

Completing the online notification form

You will need the following information to complete your online notification form:

  • manufacturer details (name and address);
  • GMDN code for the device(s);
  • classification of the device(s); and
  • description of the kind of device(s) you are preparing for supply.

Important things to note:

  • If you are an Australian-based manufacturer of the device, you will also be the sponsor. When completing the form you should select 'Australian manufacturer of a custom-made medical device'.
  • You must supply one online notification form for each 'kind of medical device' .

Definitions

A custom-made medical device is defined in the Regulations as a medical device that:

  • (a) is intended by the manufacturer to be for:
    • (i) the sole use of a particular patient (the intended recipient); or
    • (ii) the sole use of a particular health professional (the intended recipient) in the course of the health professional’s practice; and
  • (b) is manufactured by the manufacturer in accordance with a written request of a health professional (the requesting health professional) and with particular design characteristics specified by that health professional in the request (even if the design is developed in consultation with the manufacturer), where those design characteristics are intended to address:
    • (i) either or both of the anatomical and physiological features of the intended recipient; or
    • (ii) a pathological condition of the intended recipient; and
  • (c) the requesting health professional has determined is necessary to address the matters covered by paragraph (b) because there is no kind of medical device included in the Register to address those matters or to address those matters to an appropriate level.

However, a custom made medical device does not include a patient matched medical device, an adaptable medical device or other mass produced medical device.

Note

Your product is unlikely to meet the definition of a custom-made medical device if:

  • you manufacture/supply more than five of that 'kind' of medical device per year.
  • you use consistent design methodology, raw materials and manufacturing methods to make the device(s).
  • the Instructions for Use are a standard document supplied with each device of that 'kind' that you supply.

Custom-made medical devices do not include:

  • adaptable medical devices; or
  • patient-matched medical devices.

More information about adaptable and patient matched medical devices can be found in the guidance document Personalised medical devices (including 3D-printed devices) on the TGA website.

Please note: a person who modifies or adapts a medical device for an individual patient does not meet the legislative definition of a manufacturer providing the adaptation does not change the original intended purpose of the device. This exclusion is covered under subsection 41BG(3) of the Therapeutic Goods Act 1989 (the Act).

Regulation - general

Custom-made medical devices are regulated under a conditional exemption. This means that manufacturers and sponsors of custom-made medical devices do not need to apply to the TGA and include their devices in the ARTG before they are supplied, but they do need to meet certain conditions. More information about the conditions that must be met is provided in the sections below.

Note

A custom-made medical device is only exempt from the requirements to be included in the ARTG provided all of the conditions of the exemption are met. If the conditions of the exemption are not met (the custom-made device is supplied without a patient statement, for example) then supply of the device will be an offence under 41MI of the Therapeutic Goods Act 1989 (the Act). Civil penalties apply.

If you are the manufacturer or sponsor of a custom-made medical device, it is important that you understand your obligations. More information is provided in the sections below.

The TGA regulates the importation and supply of medical devices to ensure they meet required standards of quality, safety and performance as described in the Essential Principles. The TGA will not prevent the importation of a custom-made medical device providing:

  • the device meets the definition of a custom-made medical device;
  • the Essential Principles have been met; and
  • a notification of supply has been submitted to the TGA.

Requirements for sponsors and manufacturers

A sponsor is the Australian-based legal entity (a person or corporation) that manufactures or imports a medical device for supply within Australia, or who exports medical devices from Australia.

Sponsors can include:

  • medical device manufacturers, if the manufacturer is directly supplying their custom-made medical devices within, or exporting their devices from, Australia; and
  • health professionals who import custom-made medical devices for their patients.

Custom-made medical devices are exempt from inclusion in the ARTG providing they meet certain conditions but they are not exempt from regulation. Sponsors and manufacturers of custom-made medical devices must:

  • adhere to the conditions of exemption relating to:
    • information to be supplied with the device;
    • record keeping requirements;
    • annual reporting; and
    • nspection and review;
  • ensure that the custom-made medical devices that they supply conform to all applicable Essential Principles;
  • meet the ongoing responsibilities of a sponsor including ensuring advertising compliance and reporting adverse events; and
  • comply with all other relevant regulatory requirements(providing patient information leaflets and implant cards for all implantable medical devices, for example).

Information to be supplied with your device

From 25 February 2021 manufacturers are required to supply written statements prepared in relation to each of the custom-made medical devices they manufacture. The statements must include (at minimum) the following information:

  • the name and business address of the manufacturer;
  • information identifying the device or, where relevant, the contents of the packaging;
  • a statement to the effect that the device is intended to be used only in relation to a particular individual (who may be a health professional);
  • the name of the individual to whom the device is intended to be used;
  • the name and business address of the health professional who provided the specifications for the device;
  • the particular design characteristics or construction of the device as specified by the health professional who provided the specifications; and
  • a statement to the effect the device complies with the applicable provisions of the Essential Principles. If the device does not comply with all applicable provisions, then a statement must be included explaining which provisions it does not comply with and the reasons why.

The statement must be signed and dated by a person authorised by the manufacturer of the device, and include details of the person's name and position. It is the legal manufacturer of the device under section 41BD of the Act who must compile the statement, including where manufacturing steps are outsourced.

Manufacturers may choose to use the statement template included as Appendix 2 to the guidance document Personalised Medical Devices (including 3D-printed devices). Manufacturers may choose to supply the statement digitally, provided sufficient information is provided with both the statement and the device to allow the user to correctly match the two.

Note

Manufacturers should note that the requirement to supply these statements is in addition to existing requirements for information to be supplied with a device under Essential Principle 13 of Schedule 1 of the Regulations including:

  • instructions for Use; and
  • a patient implant card (PIC) or patient information leaflet (PIL) for implantable devices. (The manufacturer may choose to include the required PIC/PIL information in the statement to be supplied with the device. More information on PICs and PILs can be found on our website.)

Statements do not have to be supplied for patient-matched devices providing the device is registered for transition.

The level of information supplied in the statement will differ between devices, but it must be sufficient to allow the intended recipient(s) (in many cases, this will be both the patient and any health professional involved in their healthcare, both now and in the future) to make informed decisions that will:

  • ensure the device continues to perform as intended;
  • ensure the device can be maintained and used safely for the length of its intended life; and
  • ensure risks associated with the device can be managed.

Manufacturers of custom-made medical devices should consider, but not limit their thinking to, the following:

  • Will the intended user need to see a health professional other than the health professional that requested the device about their presenting issue, or a related issue, in the future?
  • What kind of information might be needed to safely perform a revision procedure, or a re-fit, or a modification of the device?
  • What kind of information might be needed to safely maintain the device?
  • What is the expected clinical course for this patient, and what other kinds of health
  • professionals might be involved in their care? What might they need to know?

Record-keeping requirements

Manufacturers and sponsors of custom-made medical devices must maintain records relating to the devices they have supplied in Australia for:

  • a minimum of 5 years after the date of manufacture if the device is non-implantable; or
  • a minimum of 15 years after the date of manufacture if the device is implantable.

If you are not sure whether a device you manufacture or supply is implantable, please review the definition in the dictionary section of the Regulations.

At a minimum, manufacturers and sponsors of custom-made medical devices should maintain:

  • a copy of the statement described in 3.2 Information to be supplied with your device;
  • annual reports relevant to the device;
  • evidence that the device conforms to the Essential Principles; and
  • any other documentation that they determine is needed to show that the conditions of the exemption have been met when each device was supplied.

Annual reports

Manufacturers and sponsors of custom-made medical devices must supply an annual report detailing all of the custom-made medical devices they have manufactured and/or supplied within the past 1 July – 30 June financial year.

Annual reports must include:

  • the date you notified the TGA you are manufacturing/supplying a custom-made medical device through the online reporting form;
  • the number of devices supplied in the financial year you are reporting; and
  • a declaration that you have reported adverse events associated with the use of your devices to the TGA through the online reporting system.

Note

TGA will make an online reporting form available for the submission of annual reports before the end of the 2020-2021 financial year.

Annual reports do not have to be supplied for patient-matched devices providing the device is registered for transition.

There are penalties associated with failing to provide an annual report to the TGA.

Inspection and review

The TGA has the legal authority to request the production of certain information from manufacturers and sponsors of custom-made medical devices, and allow authorised officers to inspect premises that form part of the supply chain of a custom-made medical device.

Table 1. Obligations of manufacturers and sponsors of custom-made medical devices relevant to inspections

Obligation This means that
Allow entry and inspection of premises

An authorised person (a delegated departmental officer) may:

  • enter at any reasonable time any premises – including premises outside of Australia – that is a part of the supply chain for the custom-made medical device and:
    • inspect those premises;
    • inspect the device or anything on the premises that relates to the device including: examining;
    • taking measurements; or
    • conducting tests on, or requiring tests to be conducted, on the device or any aspect of the manufacturing facility for the device; and
    • make any still or moving image or any recording of those premises of any things on those premises.
Produce documentation

An authorised person (a delegated TGA officer) may request documentation of any kind relating to the custom-made medical device including, but not limited to:

  • a copy of the original health professional’s request for the device;
    • in cases where the health professional is the manufacturer, this could be a document outlining the clinical notes taken to inform design of the device.
  • any information supplied with the device; and
  • evidence of conformity assessment documentation.

Note

Inspections are generally initiated in relation to adverse events associated with the device. The TGA will typically provide at least two (2) weeks' notice of routine domestic inspections, and four (4) weeks’ notice of routine international inspections. Notice periods may differ where inspections are being performed as part of serious compliance investigations.

Requirements for health professionals

The health professional prescribing the custom-made device is responsible for specifying its design characteristics or construction. If they are also the manufacturer or sponsor of the medical device, then they must also meet the relevant regulatory responsibilities outlined in the section for sponsors and manufacturers above.

Health professionals can import custom-made medical devices from overseas, but in doing so they meet the definition of a sponsor and are subject to the sponsor's obligations as outlined in the 'Requirements for sponsors' section above.

All custom-made medical devices must meet the Essential Principles. Essential Principle 13.1 requires devices to be supplied with information identifying the manufacturer of the device.

Suspect devices

If you have concerns about the safety or performance of a custom-made medical device, you can submit a report to the TGA. The act of reporting an event is not an admission of liability for the event or its consequences.

This can be done via the TGA Internet site, or the forms can be posted to:

Medical Devices Surveillance Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606