Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p12
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 12/40)
Character Range: 65977–68790

to the current Poisons Standard.
 (2) However, this regulation does not apply to the certificate if, under Appendix A to the current Poisons Standard, the Standard does not apply to poisons in that kind of device.
 (3) For the purposes of subsection 41EJ(5A) of the Act, the certificate is subject to the condition that the manufacturer in respect of whom the certificate is issued will not supply a medical device of that kind if the supply would contravene Part 2 of the current Poisons Standard.

Division 4.2—Suspension of conformity assessment certificates

4.4  Period for revocation of suspension (Act s 41EP, s 63(2)(db))
 (1) This regulation applies to an application to the Secretary under paragraph 41EP(2)(a) of the Act to revoke the suspension of a conformity assessment certificate.
 (2) The Secretary must make a decision on the application within 40 working days after the application is received at an office of the Department specified by the Secretary.

Division 4.3—Transfer of conformity assessment certificates

4.5  Application of Division 4.3
  This Division applies in relation to a manufacturer of a medical device in respect of whom a conformity assessment certificate is issued.

4.6  Death, bankruptcy or winding up of manufacturer
 (1) If the manufacturer dies, the manufacturer's legal personal representative:
 (a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and
 (b) must notify the Secretary, in writing, of the death not later than 3 months after it occurred.
 (2) If the manufacturer becomes bankrupt, the trustee in bankruptcy of the manufacturer's estate:
 (a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and
 (b) must notify the Secretary, in writing, of the manufacturer's bankruptcy not later than 3 months after it occurred.
 (3) If the manufacturer is a body corporate that is wound up, the liquidator of the body corporate:
 (a) is taken to be the person in respect of whom the conformity assessment certificate is issued; and
 (b) must notify the Secretary, in writing, of the winding up of the body corporate not later than 3 months after it occurred.
Note: See also regulations 4.10 and 4.11.

4.7  Disposal of business or amalgamation with another manufacturer
 (1) This regulation applies if the name of the manufacturer is changed in any of the following circumstances:
 (a) the manufacturer agrees to dispose of a business concerned with the manufacture of the medical device, and it is agreed that the 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