THERAPEUTIC GOODS ACT 1989 - SECT 41EE Procedure following making a decision whether to issue certificate

THERAPEUTIC GOODS ACT 1989 - SECT 41EE

  (1)   After making a decision whether to issue a conformity assessment certificate, the Secretary must:

  (a)   notify the applicant in writing of his or her decision within 20 working days; and

  (b)   if the decision is not to issue the certificate--state in the notice the reasons for the decision; and

  (c)   if the decision is to issue the certificate and all assessment fees that are due and payable for the application have been paid:

  (i)   issue the certificate to the manufacturer in relation to whom the application was made; and

  (ii)   give the applicant a copy of the certificate (if the applicant is not the manufacturer).

  (2)   A conformity assessment certificate must specify whether it covers:

  (a)   all medical devices manufactured by the manufacturer; or

  (b)   only specified medical devices manufactured by the manufacturer.

  (3)   A conformity assessment certificate must contain any other information prescribed by the regulations for the purposes of this subsection.