(1) When certifying the matter referred to in paragraph 41FD(f), the applicant must also state that the certification of the matter is based:
(a) on a conformity assessment certificate that is in force; or
(b) on an Australian conformity assessment body certificate that is in force; or
(c) on an overseas regulator conformity assessment document that is in force.
(2) However, subsection (1) does not apply if devices of the kind in question are class I medical devices (within the meaning of regulations made for the purposes of this Chapter).