THERAPEUTIC GOODS ACT 1989 - SECT 41EA When conformity assessment certificates are required

THERAPEUTIC GOODS ACT 1989 - SECT 41EA

    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).