Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p13
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 13/30)
Character Range: 168624–171306

and functions under these Regulations
  The Secretary may, by signed instrument, delegate a power or function of the Secretary under these Regulations to an officer of the Department.

10.6  Delegation—powers under paragraph 41HB(1)(d) of the Act
 (1) In this regulation:
delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary, under paragraph 41HB(1)(d) of the Act, to approve the use of a specified medical device or kind of medical device in the treatment of a person.
 (2) A delegate may only be a person who:
 (a) is a medical practitioner employed by an institution that has an ethics committee; and
 (b) is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.
 (3) If:
 (a) a person proposes another person under paragraph (2)(b) as a person to be a delegate; and
 (b) that other person becomes a delegate;
the first‑mentioned person must supervise each approval that the delegate grants under the delegation.
 (4) An instrument of delegation must describe the person or class of persons to be treated with the medical device or kind of medical device to which the delegation relates.
 (5) A delegation may be made for the purpose of allowing the delegate to grant an approval in relation to:
 (a) a particular medical device or kind of medical device; or
 (b) a particular class of medical devices;
for treating a specific illness or condition.
 (6) A delegate may grant an approval under a delegation only if:
 (a) a medical practitioner, other than the delegate, has stated in writing that the person who is to be treated with the medical device of a kind to which the approval relates has an illness or condition that requires treatment with that kind of medical device; and
 (b) an ethics committee has agreed to the granting of an approval under paragraph 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the kind of medical device to which the delegation relates.

10.6A  Delegation of Secretary's powers under section 41HD of the Act
  The following positions are prescribed for the purposes of subsection 57(9) of the Act:
 (a) an SES Band 1, 2 or 3 position;
 (b) each position classified as a Medical Officer Class 3, 4, 5 or 6;
 (c) an Executive Level 1 or 2 position.

10.6B  Forms or manners—software requirements
  If a provision of these Regulations provides for the approval or specification of a form or manner of giving an application, notice or other document, the approval