THERAPEUTIC GOODS ACT 1989 - SECT 41FI Auditing of applications

THERAPEUTIC GOODS ACT 1989 - SECT 41FI

  (1)   In auditing the application, the Secretary may consider all or some aspects of one or both of the following matters:

  (a)   whether the application is in accordance with Subdivision A;

  (b)   whether matters as to which the applicant has certified under section   41FD are correct.

  (1A)   In auditing the application, the Secretary may, by written notice given to the applicant, require the applicant:

  (a)   to deliver to the office to which the application was made a reasonable number of samples of the kind of medical device to which the application relates within the period, of not less than 14 days after the day the notice is given, specified in the notice; and

  (b)   to do so in a manner specified in the notice.

  (2)   The Secretary must decide to include the kind of device to which the application relates in the Register, in relation to the person to whom the application relates, if the Secretary is satisfied as to all such aspects considered in the audit.

  (3)   The Secretary must decide not to include the kind of device to which the application relates in the Register if the Secretary is not so satisfied.