Document ID: chunk:federal_register_of_legislation:C2024C00632:section:41m
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 41M
Character Range: 819325–820139

41M  What this Part is about

      This Part contains offences and civil penalty provisions that are aimed at ensuring that:
         • the essential principles are complied with (see Division 1);
         • the conformity assessment procedures have been applied to kinds of medical devices or requirements, comparable to those procedures, have been applied to kinds of medical devices (see Division 2);
         • administrative processes put in place by Parts 4‑4 to 4‑9 are followed (see Divisions 3, 3A and 4).
Note: There are also some offences and civil penalty provisions in the earlier Parts of this Chapter. They generally relate to matters ancillary to administrative processes in those Parts (e.g. false or misleading statements in applications).

Division 1—Non‑compliance with essential principles