Therapeutic Goods Regulations 1990

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

If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.

The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.

If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:

amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and

as soon as practicable after entering the new name:

inform the person that the new name has been entered in the Register; and

make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.