(1)

For subsection 41JD (2) of the Act, a statement by a medical practitioner in relation to the use of an exempt device in or on a person who is a Category A patient must include the following:

(a)

the initial letters of the person's given name and surname, and the person's date of birth and sex;

(b)

the diagnosis of the person's condition;

(c)

the expected duration of the treatment;

(d)

a description of the exempt device;

(e)

the supplier of the exempt device;

(f)

the number of units of the exempt device to be supplied;

(g)

the treating medical practitioner's name, practising address and other contact details;

(h) a statement to the effect that:

(i)

the person in or on whom the exempt device is to be used 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.

(2)

The medical practitioner who signs the statement must send a copy of the statement to the Secretary within 20 working days after signing it.

Penalty:
10 penalty units.

(3)

An offence against subregulation (2) is an offence of strict liability.

Note
For strict liability , see section 6.1 of the Criminal Code .

(4)

In this regulation:

"Category A patient" has the same meaning as in regulation 7.2.

"informed consent" has the same meaning as in regulation 7.2.