Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(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) a statement in relation to the person is completed in accordance with subregulation (1A);
(iii) the device is used in accordance with the direction of the medical practitioner who requested its use.
(1A) For the purposes of subparagraph (1)(b)(ii), a statement in relation to the use of an exempt device in or on a person who is a Category A patient must:
(a) be completed by:
(i) the medical practitioner by whom, or at whose direction, the device is used; or
(ii) by a health practitioner acting on behalf of that medical practitioner; and
(b) be in the form approved by the Secretary for the purposes of this paragraph; and
(c) include the following:
(i) the initial letters of the person's given name and surname, and the person's date of birth and sex;
(ii) the diagnosis of the person's condition;
(iii) the expected duration of the treatment;
(iv) a description of the exempt device;
(v) the supplier of the exempt device;
(vi) the number of units of the exempt device to be supplied;
(vii) the treating medical practitioner's name, practising address and other contact details; and
(d) include a statement to the effect that:
(i) the person is a Category A patient; and
(ii) the person, or the person's guardian, has given informed consent to the use of the device in or on the person.
(1C) A person commits an offence of strict liability if the person:
(a) completes a statement referred to in subparagraph (1)(b)(ii); and
(b) does not send a copy of the statement to the Secretary within 28 days after the use of the exempt device to which the statement relates.
(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.