Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41e
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41E
Character Range: 39674–40443

41E  What this Part is about

      The Secretary can issue a conformity assessment certificate (which may be limited to some medical devices) in respect of a manufacturer of medical devices, signifying one or more of these:

                (a) that relevant quality management systems have been applied to the device;
                (b) the essential principles for the device have been complied with;
                (c) other certification requirements of the conformity assessment procedures have been met.
Note: A conformity assessment certificate may be required before a valid application can be made for including a kind of medical device in the Register under this Chapter: see subsection 41FC(2).

Division 1—Issuing conformity assessment certificates