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Regulatory changes for custom-made medical devices

Feb 4, 2021

On 25 February 2021, the Australian Government will introduce changes to the Therapeutic Goods (Medical Devices) Regulations 2002 which will result in new definitions and regulatory requirements for therapeutic goods currently known as custom-made medical devices.

Under the new framework, the new regulatory requirements will:

* introduce new definitions for personalised medical devices, thereby reducing the scope of the existing definition of a custom-made medical device;

* change the conditions of exemption for custom-made medical devices to:

(a) require annual reporting of custom-made devices supplied in the previous financial year;

(b) allow the Therapeutic Goods Administration to inspect production facilities;

(c) require documentation about the device to be retained for 5 years (for non-implantable devices) or 15 years (for implantable devices); and

(d) require manufacturers to provide information about each custom-made medical device to the intended recipient.

(e) introduce the new concept of a Medical Device Production System (MDPS) and a framework for regulating these systems to allow healthcare providers to produce personalised devices for treating their patients, without the need for manufacturing certification; and

(f) update the classification rule for medical devices that record diagnostic images to include a broader range of technology now used for the purposes of recording patient anatomy for diagnosis and investigation, including anatomical models.

New definitions for personalised medical devices

Custom-made medical device: a medical device that is a rare, one-off, bespoke piece designed and manufactured for patients whose treating health professional has determined that the patient’s anatomical or physiological features, or pathological condition, make them unsuitable candidates for patient-matched or adaptable medical devices that are included in the Australian Register of Therapeutic Goods (ARTG).

Patient-matched medical device: a medical device that is designed and manufactured within a specified design envelope to match the anatomical and/or physiological features of a particular individual; or a pathological condition of a particular individual. A patient-matched device is manufactured using production processes capable of being validated and/or verified and reproduced.

Devices produced using a Medical Device Production System: a Medical Device Production System (MDPS) is a complete system supplied to a health professional or healthcare facility so that personalised medical devices can be manufactured by a health professional (or other suitably qualified person within the healthcare facility).

Adaptable medical device: a mass-produced medical device intended by the manufacturer to be assembled or adapted after it is supplied, in accordance with the manufacturer’s instructions, to address either or both of the anatomical and physiological features of a particular individual; or address a pathological condition of a particular individual; or otherwise perform as intended by the manufacturer.

Further information on the definitions and new regulatory requirements for personalised medical devices can be viewed here.

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