Therapeutic Goods Act 1989

The Minister may, by legislative instrument, make an order determining that:

matters specified in the order constitute a conformity assessment standard for quality management systems identified in the order; and

a quality management system that complies with the standard is to be treated as having had applied to it those parts of the conformity assessment procedures specified in the standard.

Section 12 of the Legislation Act 2003 deals with when a legislative instrument commences.

A conformity assessment standard may be limited to particular kinds of medical devices.

The Minister may, by legislative instrument, vary or revoke an order made under subsection (1).

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.