Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p18
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 18/43)
Character Range: 386509–389307

and the documents relating to those procedures;
 (ii) the procedures to be used for purchasing goods or services in relation to the production of the kind of device produced and the documents relating to those procedures;
 (iii) product identification procedures to be prepared and kept up‑to‑date from drawings, specifications or other documents at each stage of manufacture;
 (d) the tests or trials to be carried out before, during and after production of the kind of medical device to which the system is to be applied, including, in particular, information about:
 (i) the frequency with which the tests or trials are to be carried out; and
 (ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials;
 (e) the system for reviewing experience gained in the post‑production phase in relation to the kind of medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied in relation to the design or production of such devices;
 (f) whether a conformity assessment standard has been applied to the system and, if no conformity assessment standard, or part only of a conformity assessment standard, has been applied to the system—the solutions adopted to ensure that the system complies with subclause (2).

4.5  Changes to production quality management system
 (1) This clause applies to the manufacturer of a medical device if:
 (a) the manufacturer has implemented, and had assessed under clause 4.3 of this Schedule, a quality management system that is to be applied to the device; and
 (b) after assessment, the manufacturer plans to make a substantial change to the system.
 (2) The manufacturer must:
 (a) notify the Secretary or an Australian conformity assessment body, in writing, of the proposed change; and
 (b) arrange for assessment of the change by the Secretary or the Australian conformity assessment body to verify whether the system, as changed, meets the requirements of clause 4.4 of this Schedule.
 (3) For the purpose of enabling the assessment to be carried out, the manufacturer must have available, in writing, details of any consequential changes to the information and documentation required under subclause 4.3(2) of this Schedule in relation to the system.
 (4) After any change to the quality management system, the manufacturer must ensure that the changed system continues to meet the requirements of clause 4.4 of this Schedule.

4.6  Information to be given to authorised person
 (1) If requested to do so by an authorised person, the manufacturer of a medical device must:
 (a) give to the Secretary the following information in relation to the quality management system or the kinds of medical device