Australia Therapeutic Goods (Medical Devices) Regulations 2002 r7.2: Category A patients: use an unapproved device only with informed consent and at the treating medical practitioner's direction, complete the approved Category A statement, and send it to the Secretary within 28 days of use

What does r7.2 require?

A device may be used without ARTG inclusion on a Category A patient (seriously ill and reasonably likely to die within a year, or to die prematurely without early treatment) only if the patient or guardian has given informed consent, a statement in the approved form is completed by the medical practitioner (or a health practitioner acting for them) giving the patient's initials, date of birth and sex, diagnosis, expected treatment duration, device description, supplier, number of units and the practitioner's details and confirming Category A status and informed consent, and the device is used as that practitioner directs. Whoever completes the statement must send a copy to the Secretary within 28 days of the use, a strict liability offence (10 penalty units).