Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41ec
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41EC
Character Range: 42640–43344

41EC  Considering applications

 (1) If the application is made in accordance with section 41EB, the Secretary must decide whether to issue the conformity assessment certificate.

 (2) In deciding whether to issue the certificate, the Secretary must consider some or all aspects of whether the conformity assessment procedures relating to one or more of the following have been applied to the medical device:
 (a) the application of quality management systems for the manufacture of medical devices;
 (b) the certification of compliance with the essential principles;
 (c) any other requirement of the conformity assessment procedures specified in regulations made for the purposes of this subsection.