Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p15
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 15/43)
Character Range: 378814–381621

keep the records for at least 5 years after the manufacture of the last medical device to which the verification relates.
 (3) On request from the Secretary, the manufacturer must make the records available to the Secretary.

Part 4—Production quality assurance procedures

4.1  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 production 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) to allow the Secretary or an Australian conformity assessment body to monitor the operation of, and carry out inspections of, the system; and
 (c) to make a declaration of conformity in relation to the kind of device; and
 (d) to:
 (i) notify the Secretary or an Australian conformity assessment body of any change to the system; and
 (ii) arrange for assessment of any such change by the Secretary or an Australian conformity assessment body; and
 (e) 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.

4.2  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.

4.3  Implementation and assessment of production quality management system
 (1) The manufacturer of a medical device must:
 (a) implement a quality management system for the production 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 kinds 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) for a kind of device in relation to which the type examination procedures have been applied—evidence that the device conforms to the approved type and a copy of the technical documentation required under subclause 2.3(3) of the type examination procedures for the approved type;
 (h) for a kind of device to which the