Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41ee
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41EE
Character Range: 43934–44840

41EE  Procedure following making a decision whether to issue certificate

 (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.