Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41EA

When conformity assessment certificates are required

                   The regulations may prescribe:

                     (a)  kinds of manufacturers in respect of whom a conformity assessment certificate must be issued before valid applications can be made for kinds of medical devices, manufactured by those manufacturers, to be included in the Register; or

                     (b)  kinds of medical devices in respect of which a conformity assessment certificate must be issued before valid applications can be made for those kinds of medical devices to be included in the Register.

Note:          The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices: see subsection 41LA(2).



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