Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:10f:p1
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 10F (pt 1/2)
Character Range: 152119–154640

10F  Change of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act

Application
 (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.

Death of person
 (2) If the relevant person dies, the legal personal representative (the notifying person) of the dead person:
 (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and
 (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.

Bankruptcy of person
 (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:
 (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and
 (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.

Winding up of body corporate
 (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:
 (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and
 (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.

Transfer or assignment of business
 (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person's interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:
 (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and
 (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.

Secretary may request further information
 (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further