THERAPEUTIC GOODS ACT 1989 - SECT 41CB Medical device standards
THERAPEUTIC GOODS ACT 1989 - SECT 41CB
Medical device standards(1) The Minister may, by legislative instrument, make an order determining that:
(a) matters specified in the order constitute a medical device standard for kinds of medical devices identified in the order; and
(b) medical devices of those kinds that comply with the standard are to be treated as complying with those parts of the essential principles specified in the standard.
Note: Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences.
(2) The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).
(3) Despite subsection 14(2) of the Legislation Act 2003
, an order under subsection (1) of this section, or a variation of such
an order, may make provision in relation to a matter by applying, adopting or
incorporating, with or without modification, any matter contained in an
instrument or other writing as in force or existing from time to time.