Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41hb:p1
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41HB (pt 1/2)
Character Range: 95467–98172

41HB  Exemptions for special and experimental uses

 (1) The Secretary may grant a written approval to a person for:
 (a) the importation into Australia; or
 (b) the exportation from Australia; or
 (c) the supply in Australia;
of a specified medical device or kind of medical device (other than medical devices included in the Register or exempt devices):
 (d) for use in the treatment of another person; or
 (e) for use solely for experimental purposes in humans.

 (2) The approval may be given subject to conditions specified in the approval, including a condition relating to charging for medical devices of the kinds in question.

Note: Breach of the conditions may be an offence: see subsection 41MN(3).

 (3) In addition, the regulations may prescribe conditions that apply to a person's approval to use specified kinds of medical devices solely for experimental purposes in humans. The conditions may relate to one or more of the following:
 (a) the preconditions on another person's use of devices of those kinds for those purposes;
 (b) the principles to be followed in another person's use of devices of those kinds for those purposes;
 (c) the monitoring of another person's use, and the results of that use, of devices of those kinds for those purposes;
 (d) the circumstances in which that other person must cease using devices of those kinds for those purposes.

 (4) An application to use specified medical devices in the treatment of another person must be accompanied by any information about the devices that is required by the Secretary.

 (5) An application to use specified kinds of medical devices solely for experimental purposes in humans must:
 (a) be made in writing; and
 (b) be accompanied by any information about the kinds of devices that is required by the Secretary; and
 (c) be accompanied by the prescribed fee.

 (6) The Secretary must:
 (a) consider any application under this section; and
 (b) assess any information submitted with the application; and
 (c) notify the applicant, within 20 working days of making the decision:
 (i) of the decision; and
 (ii) in the case of a decision not to grant the approval—of the reasons for the decision.

 (7) The use by a person for experimental purposes in humans of specified kinds of medical devices that are the subject of an approval granted to someone else under paragraph (1)(e) is subject to the conditions (if any) specified in the regulations relating to one or more of the following:
 (a) the preconditions on the use of devices of those kinds for those purposes;
 (b) the principles to be followed in the use of devices of those kinds for those purposes;
 (c) the monitoring of the use, and the results of the use,