Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 1/43)
Character Range: 343089–345909

Schedule 3—Conformity assessment procedures
(regulation 3.4)

Part 1—Full quality assurance procedures

1.1  Overview
  The conformity assessment procedures set out in this Part provide for the manufacturer of a kind of medical device:
 (a) to:
 (i) implement a quality management system for the design, production, packaging, labelling and final inspection of the kind of device; and
 (ii) arrange for assessment of the system by the Secretary or an Australian conformity assessment body; and
 (b) for a Class 4 IVD medical device, Class 4 in‑house IVD medical device or Class III medical device—to arrange for examination of the design of the kind of device by the Secretary or an Australian conformity assessment body; and
 (c) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and
 (d) to make a declaration of conformity in relation to the kind of device; and
 (e) to:
 (i) notify the Secretary or an Australian conformity assessment body of any change to the system, or to the kinds of devices to which the system is to be applied; and
 (ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and
 (f) to establish and keep up‑to‑date a post‑market monitoring, reporting and corrective action system.
Note: See Division 3.2 in relation to the kinds of medical devices to which these conformity assessment procedures may be applied.

1.2  References to kinds of medical devices
  A reference in this Part to a kind of medical device includes a reference to an individual medical device.

1.3  Implementation and assessment of quality management system
 (1) The manufacturer of a kind of medical device must:
 (a) implement a quality management system for the design, production, packaging, labelling and final inspection of the kind of device; and
 (b) arrange for assessment of the system by the Secretary or an Australian conformity assessment body.
 (2) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, the following information and undertakings:
 (a) the name and business address of the manufacturer;
 (b) details of each manufacturing site where the system is to be applied;
 (c) all relevant information about the kind of medical devices to which the system is to be applied;
 (d) the documentation in relation to the system;
 (e) an undertaking by the manufacturer to continue to comply with the requirements of the system after assessment;
 (f) an undertaking by the manufacturer to ensure that the system is at all times adequate and efficacious;
 (g) an undertaking by the manufacturer:
 (i) if the manufacturer arranged for assessment of the system by the Secretary—to notify the Secretary, or the