Document ID: chunk:federal_register_of_legislation:C2007C00652:clause:1_41d
Version: federal_register_of_legislation:C2007C00652
Segment Type: clause
Provision Reference: sch 1 cl 41D
Character Range: 34792–35503

41D  What this Part is about

      The conformity assessment procedures set out the requirements relating to the application of quality management systems for medical devices, and other requirements imposed on manufacturers.
      Compliance with applicable conformity assessment standards is not required, but it is one way to establish that one or more parts of the conformity assessment procedures have been applied to medical devices.
Note 1: Dealing in medical devices that have not had the conformity assessment procedures applied may be an offence: see Division 2 of Part 4‑11.

Note 2: See section 41BI on applying the conformity assessment procedures.

Division 1—Conformity assessment procedures