Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) This regulation applies to a conformity assessment certificate that covers a kind of medical device that contains a substance of a kind covered by an entry in a Schedule 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.