Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) If a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act dies, the legal personal representative of the person:
(a) is taken to be the person in relation to whom the kind of device is included in the Register under that Chapter; and
(b) must notify the Secretary, in writing, of the death within 3 months after it occurred.
(2) If a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act becomes bankrupt, the trustee in bankruptcy 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 that Chapter; and
(b) must notify the Secretary, in writing, of the bankruptcy within 3 months after the person became bankrupt.
(3) If a body corporate in relation to which a kind of medical device is included in the Register under Chapter 4 of the Act is wound up, the liquidator 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 that Chapter; and
(b) must notify the Secretary, in writing, of the winding up within 3 months after the body corporate is wound up.
(4) If a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act:
(a) changes his, her or its name; or
(b) being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register;
the person must, within 3 months after the change of name or amalgamation:
(c) notify the Secretary, in writing, of the new name of the person and the circumstance giving rise to it; and
(d) return the certificate of the inclusion of the kind of device in the Register given under subsection 41FF (2) of the Act.
(4A) If a person for whom a kind of medical device is included in the Register under Chapter 4 of the Act 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, the person to whom the business or interest is transferred or assigned:
(a) is taken, to the extent of the business or interest transferred or assigned, to be the person for whom the medical device is included in the Register under Chapter 4 of the Act; and
(b) must, within 3 months after the transfer or assignment, notify the Secretary in writing of the transfer or assignment.
(5) If a person notifies the Secretary of an event under paragraph (1) (b), (2) (b), (3) (b) or (4A) (b), or a change of name under subregulation (4), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
(6) If, under subregulation (4), the Secretary is notified of a new name for a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act, the Secretary must:
(a) enter the new name in the Register as the name of the person in relation to whom the kind of device is included in the Register under that Chapter; and
(b) as soon as practicable after entering the new name, give to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.
(7) If, at any time, the Secretary becomes aware that he or she has not been informed of a change in the name of a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act, the Secretary may cancel the entry in the Register in relation to the kind of device.
(8) If, under this regulation, the Secretary:
(a) changes the name of a person in relation to whom a medical device is included in the Register under Chapter 4 of the Act; or
(b) cancels an entry in the Register in relation to a kind of medical device;
the Secretary must, as soon as practicable after changing the name or cancelling the entry:
(c) notify the person in relation to whom the kind of device was included in the Register that the name has been changed or the entry in the Register has been cancelled; and
(d) ask the person to return to the Secretary the certificate of the inclusion of the kind of device in the Register given under subsection 41FF (2) of the Act.
(9) If a person in relation to whom a kind of device is included in the Register under Chapter 4 of the Act receives a notice under subregulation (8), the person must return to the Secretary, as soon as practicable after receiving the notice, the certificate of the inclusion of the kind of device in the Register under that Chapter that was given before the change of name or cancellation.
Penalty: 5 penalty units.
(10) An offence against subregulation (9) is an offence of strict liability.
Note For strict liability , see section 6.1 of the Criminal Code .