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 ARTG if they are being supplied in volumes of more than 5 per financial year. You must notify the Therapeutic Goods Administration (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. You are required to notify the TGA within two months of manufacture or initial supply of the custom-made medical device.
A custom-made medical device is defined in the Therapeutic Goods (Medical Devices) Regulations 2002 (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.
It is important to note that while custom-made medical devices are exempt from inclusion in the ARTG, but they are not exempt from regulation. Sponsors and manufacturers of custom-made medical devices must:
- • notify the TGA they are manufacturing and/or importing custom-made medical devices;
- • adhere to the conditions of exemption relating to inspection and review;
- • adhere to the record keeping requirements;
- • supply their devices with all relevant information required;
- • provide an annual report to the TGA between 1 July and 1 October each year for the preceding year, detailing all of the custom-made medical devices they have manufactured and/or supplied. The report must be submitted in the approved format by 1 October of the following financial year; and
- • not advertise the custom-made medical devices they supply to consumers.
Additionally, sponsors and manufacturers of custom-made medical devices need to comply with standard regulatory requirements including
- • ensure the custom-made medical devices 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 (for example, providing patient information leaflets and implant cards for all implantable medical devices).
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. At a minimum, manufacturers and sponsors of custom-made medical devices should maintain a copy of the statement described in Information to be supplied with your device below, annual reports relevant to the device, evidence that the device conforms to the Essential Principles, and any other documentation.
Manufacturers of custom-made medical devices must 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 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 Therapeutic Goods Act 1989 (the Act) who must compile the statement, including where manufacturing steps are outsourced.
If a device you manufacture or import is impacted by this change and requires inclusion on the ARTG, there are transition arrangements in place until 1 November 2024 to allow you to complete this process. To access the transition period, you will need to register using the online form before 25 August 2022.