Commonwealth Consolidated Acts

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Overseas regulators

             (1)  An overseas regulator is a body determined in an instrument under subsection (2).

             (2)  The Secretary may, by notifiable instrument, determine a body for the purposes of subsection (1). The Secretary must be satisfied that the body:

                     (a)  is established outside Australia; and

                     (b)  is empowered to issue certificates or other documents to the effect that the body is satisfied that requirements, comparable to the conformity assessment procedures, have been applied to medical devices by the manufacturers of the devices.

             (3)  Without limiting subsection (2), the Secretary may determine a body by reference to a designation, recognition, approval or authorisation (however described) of the body:

                     (a)  by one or more countries; or

                     (b)  by another body.

Note:          For specification by class, see subsection 13(3) of the Legislation Act 2003 .

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