Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p13
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 13/40)
Character Range: 68531–71328

disposal is to include a transfer of the conformity assessment certificate issued in respect of the manufacturer and the medical device;
 (b) in the case of a manufacturer that is a body corporate—the manufacturer amalgamates with another body corporate under a name that is different from the name of the manufacturer on the conformity assessment certificate.
 (2) The person to whom the business is disposed of, or the body corporate with whom the manufacturer amalgamates:
 (a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and
 (b) must, not later than 3 months after the disposal or amalgamation, apply to the Secretary, in writing, for the name of the manufacturer to be changed on the conformity assessment certificate.

4.8  Change of name of manufacturer
  If the name of the manufacturer is changed:
 (a) the manufacturer, as renamed, is taken to be the person in respect of whom the conformity assessment certificate is issued; and
 (b) the manufacturer must, not later than 3 months after the name is changed, notify the Secretary, in writing, of the new name and the circumstances in which the change occurred.
Note: See also regulations 4.10 and 4.11.

4.9  Effect of conformity assessment certificate after transfer, etc
  If a conformity assessment certificate is taken to be issued in respect of a person because of the operation of regulation 4.6, 4.7 or 4.8:
 (a) the certificate has effect as if it had actually been issued in respect of that person; and
 (b) the medical devices to which the certificate relates may continue to be manufactured while the certificate is in effect.

4.10  Notification to Secretary of events
 (1) If a person is required to notify the Secretary of an event under this Division, the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.
 (2) If, at any time, the Secretary becomes aware that he or she has not been notified of an event as required by this Division, the Secretary may suspend or revoke the conformity assessment certificate to which the event relates.

4.11  Notification of change of name or suspension or revocation of conformity assessment certificate
 (1) If, under this Division, the Secretary:
 (a) changes the name of a manufacturer on a conformity assessment certificate; or
 (b) suspends or revokes a conformity assessment certificate issued in respect of a manufacturer;
the Secretary must, as soon as practicable after changing the name or suspending or revoking the conformity assessment certificate:
 (c) notify the manufacturer that the name has been changed or the conformity assessment certificate has been suspended or revoked; and
 (d) ask the manufacturer to return to the Secretary the conformity