Document ID: chunk:federal_register_of_legislation:C2017A00047:clause:3_24
Version: federal_register_of_legislation:C2017A00047
Segment Type: clause
Provision Reference: sch 3 cl 24
Character Range: 26555–28867

24  After subsection 41HC(5)
Insert:
 (6) The Minister may, by legislative instrument, make rules authorising any health practitioner who is included in a specified class of health practitioners to supply a specified kind of medical device, for use in the treatment of humans, to the class or classes of recipients specified in those rules, so long as:
 (a) that kind of medical device is supplied in the circumstances specified in those rules; and
 (b) the conditions (if any) specified in those rules are satisfied.
 (6A) In making rules under subsection (6), the Minister must comply with:
 (a) such requirements (if any) as are prescribed by the regulations; and
 (b) such restrictions (if any) as are prescribed by the regulations; and
 (c) such limitations (if any) as are prescribed by the regulations.
 (6B) If:
 (a) a person is authorised, by subsection (6) rules, to supply a specified kind of medical device; and
 (b) the person supplies a medical device of that kind in accordance with those rules;
the person must:
 (c) notify the supply to the Secretary; and
 (d) do so within 28 days after the supply.
 (6C) A notification under subsection (6B) must:
 (a) be in accordance with a form that is approved, in writing, by the Secretary; and
 (b) contain such information as is prescribed by the regulations.
 (6D) An approval of a form may require or permit information to be given in accordance with specified software requirements:
 (a) on a specified kind of data processing device; or
 (b) by way of a specified kind of electronic transmission.
 (6E) A person commits an offence if:
 (a) the person is subject to a requirement under subsection (6B); and
 (b) the person omits to do an act; and
 (c) the omission breaches the requirement.
Penalty: 10 penalty units.
 (6F) An offence against subsection (6E) is an offence of strict liability.
Note: For strict liability, see section 6.1 of the Criminal Code.
 (6G) In recommending to the Governor‑General that regulations should be made for the purposes of paragraph (6C)(b), the Minister must have regard to the principle that information should only be prescribed for the purposes of that paragraph if the information is reasonably required for the responsible scrutiny by the Secretary of the operation of the scheme embodied in subsection (6).