What this Part is about
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).
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).
This Act’s bill:Second reading speech
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