Commonwealth Consolidated Regulations

THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002 - REG 4.11

  (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 assessment certificate that was given before the change of name or suspension or revocation.

  (2)   If a manufacturer receives a notice under subregulation   (1), the manufacturer must return to the Secretary, as soon as practicable after receiving the notice, the conformity assessment certificate that was given before the change of name or suspension or revocation.

Penalty:   5 penalty units.

  (3)   An offence against subregulation   (2) is an offence of strict liability.

Note:   For strict liability , see section   6.1 of the Criminal Code .