Information for sponsors, health professionals & manufacturers
The way that custom-made medical devices are regulated is changing
From 25 February 2021, a new framework for regulating personalised medical devices will commence. The framework includes a new definition for custom-made medical devices. The impact of the new definition is the majority of devices currently supplied under the exemption for custom-made medical devices will no longer meet the definition of a custom-made medical devices and will need to be included in the Australian Register of Therapeutic Goods (ARTG).
Transition arrangements are available to allow continued supply of your devices until 1 November 2024. To access the transition period, you must submit the following 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, is available on our website: Personalised medical devices (including 3D-printed devices)
Notify the TGA
Under Regulation 10.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 you are required to notify the TGA of specific details about a custom-made medical device if you are:
- the Australian manufacturer of a custom-made medical device, or
- an Australian sponsor (supplier) of a custom-made medical device that was manufactured overseas.
Notification is required within two months of manufacture or initial supply of the custom-made medical device.
This notification form is provided for your convenience to simplify the process.
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Definitions
- What are custom-made medical devices?
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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.
- Are medical devices that are adapted for an individual considered to be custom-made?
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custom-made medical devices do not include off-the-shelf medical devices that have been adapted or modified to accommodate an individual patient. Devices that require modification must be included in the Australian Register of Therapeutic Goods (ARTG) before they are supplied.
It is important to note that the person who adapts a medical device for an individual patient does not meet the legislative definition of a manufacturer providing the adaptation does not alter its intended purpose. This exclusion is covered under subsection 41BG(3) of the Therapeutic Goods Act 1989 (the Act).
Regulation - general
- How are custom-made devices regulated?
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Custom-made medical devices are exempt from the requirement to be included in the ARTG and do not need to undergo pre-market assessment by a third party before they can be supplied. Although custom-made medical devices are exempt from inclusion in the ARTG, they must still meet certain regulatory requirements.
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.
- Can the TGA prevent custom-made devices from being imported?
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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. Providing a custom-made medical device meets the Essential Principles and a notification of supply is submitted, the TGA will not prevent its importation.
- What or who is the sponsor of custom-made medical devices?
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A sponsor is the Australian-based legal entity (a person or corporation) that imports or supplies medical devices in Australia, or exports medical devices from Australia.
Sponsors can include:
- the manufacturer of the device, if the manufacturer is directly supplying their custom-made medical devices within, or exporting from, Australia; and
- a health professional who imports custom-made medical devices for their patients.
- What are the requirements for sponsors of custom-made medical devices?
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The sponsor must:
- ensure that the manufacturer is aware of their responsibilities for manufacturer custom-made devices under the therapeutic goods legislation;
- report all adverse events associated with the devices they supply to the TGA;
- notify the TGA under section 41MP of the Act of the following:
- any malfunction or deterioration in the characteristics or performance of the device;
- any inadequacy in the design, production, labelling, instructions for use or advertising material for the device
- any use of the device that has led to, or potentially may lead to, the death or serious deterioration in the health of the patient or user of the custom-made device
- any information relating to technical or medical reason for a malfunction or deterioration of a custom-made device that has led the manufacturer to recover the device
- any information that indicates the device does not comply with the essential principles.
Please note: It is mandatory for medical device sponsors and manufacturers to report adverse events associated with a medical device to the TGA.
Requirements for health professionals
- What are the responsibilities of health professionals prescribing custom-made devices?
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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.
- Can health professionals import custom-made medical devices?
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Health professionals can import custom-made medical devices from overseas, but in doing so they become the sponsor and are subject to the sponsor's obligations as outlined above.
- Are health professionals obliged to tell patients if a custom-made device is manufactured overseas?
- 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.
Requirements for manufacturers
- What are the requirements for manufacturers of custom-made medical devices?
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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 (Schedule 1 of the Regulations);
- Maintain specific records pertaining to each of the devices they manufacture; and
- Must notify the TGA of any adverse events involving these devices.
Please note: It is mandatory for medical device sponsors and manufacturers to report adverse events associated with a medical device.
Suspect devices
- What do I do if I find a suspect medical device?
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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 Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
