41FDA
In forceBasis of certification of conformity assessment procedures
Volume 2s 41B-Endnotes
Chapter 4Medical devices
Part 4-5Including medical devices in the Register
Division 1Including medical devices in the Register
Subdivision AApplications
41FDA Basis of certification of conformity assessment procedures
(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).
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