(1)

For paragraph 41HA (1) (b) of the Act, and without limiting regulation 7.1, a kind of medical device is exempt from the operation of Division 3 of Part 4-11 of the Act if:

(a)

the kind of device is to be used in or on a person who is a Category A patient; and

(b) the following conditions are satisfied in relation to the use of the device:

(i)

the person in or on whom the kind of device is to be used, or the person's guardian, has given informed consent to the use of the device in or on the person;

(ii)

the medical practitioner by whom, or at whose direction, the device is to be used has signed a statement in accordance with regulation 8.2;

(iii)

the device is used in accordance with the direction of the medical practitioner who requested its use.

(2) In this regulation:

"Category A patient" means a person who is seriously ill with a condition that is reasonably likely to lead to the person's death within less than a year or, without early treatment, to the person's premature death.

"informed consent", in relation to treatment or proposed treatment of a person, means consent to the treatment of the person that is freely given on the basis of information concerning the potential risks and benefits of the treatment that is sufficient to allow the person, or the person's guardian, to make an informed decision about whether to consent to the treatment.