Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41e
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41E
Character Range: 661798–662546

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 for an application to include a kind of medical device in the Register to pass preliminary assessment: see paragraph 41FDB(2)(e).

Division 1—Issuing conformity assessment certificates