Commonwealth Consolidated Acts

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THERAPEUTIC GOODS ACT 1989 - SECT 41LA

Assessment fees

  (1)   A conformity assessment fee specified in or determined in accordance with the regulations is payable by a person in respect of consideration of an application for a conformity assessment certificate under Part   4 - 4.

  (2)   The regulations may prescribe different levels of conformity assessment fees in relation to any one or more of the following:

  (a)   different kinds of manufacturers;

  (b)   different kinds of medical devices;

  (c)   different parts of the conformity assessment procedures that are considered in relation to an application for a conformity assessment certificate under Part   4 - 4.

  (3)   An application audit assessment fee specified in or determined in accordance with the regulations is payable by a person in respect of the auditing of an application for inclusion of a kind of medical device in the Register under Part   4 - 5, if paragraph   41FH(1)(a) required the Secretary to select the application for audit.

  (4)   The regulations may prescribe different levels of application audit assessment fees in relation to any one or more of the following:

  (a)   different kinds of manufacturers;

  (b)   different kinds of medical devices;

  (c)   different levels of assessment of kinds of medical devices.

  (5)   The application audit assessment fee payable because of subsection   (3) is payable only in respect of considering the matters set out in subsection   41FI(1).


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